—#171729

Product

POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063377, K122899
Affected lot / code info: REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162 and REBR1150

Why it was recalled

Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.

Root cause (FDA determination)

Device Design

Action the firm took

On June 25, 2018 Bard sent recall notifications to all their customers informing them of the following: "This letter is to inform you of a voluntary product recall issued by Bard Peripheral Vascular, Inc. (BPV), a wholly owned subsidiary of Becton, Dickinson and Company. Specific product code / lot number combinations of the NAUTILUS DELTA" Port Kits are affected as outlined in Attachment 3. These product code / lot number combinations cannot be used with the NAUTILUS DELTA" Tip Confirmation System (TCS), product code 9770323. All other product code / lot number combinations not listed in Attachment 3 can continue to be used by your facility as they are safe to use and are not affected by this product recall. Reason for Recall: Per the current Instructions for Use (IFU), the NAUTILUS DELTA" TCS can be used with implantable ports; however, BPV has identified that the NAUTILUS DELTA" Port Kit product code / lot number combinations listed in Attachment 3 may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS. During port placement procedures, once the guidewire and dilator have been removed and the catheter is inserted into the introducer sheath, the catheter is flushed with saline through the port flushing hub with attached NAUTILUS DELTA" E Electrical Adaptor (provided with the NAUTILUS DELTA" Port Kits). This should cause an intravascular ECG waveform to appear; however, in multiple instances, it has been reported that no intravascular waveform is generated or the intravascular waveform is generated and subsequently lost. Clinical Risk Statement: The loss of or lack of intravascular signal while advancing the port catheter eliminates the devices intended use, which is to provide catheter tip navigation and positioning guidance based on specified ECG signals. This lack of consistent intravascular signal may lead to a prolonged procedure or inabi

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA

Timeline

Recall initiated: 2018-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.