MAUDE Adverse Event Report: ABBOTT VASCULAR BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE; EMBOLIC PROTECTION SYSTEM

Model Number 22440-31

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause to the reported difficulties.It is possible that the kinked barewire resulted in the reported difficulties; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.The emboshield nav6 device referenced is filed under separate medwatch report number.

Event Description

It was reported the procedure was to treat a lesion with moderate calcification in the right superficial femoral artery (sfa) the emboshield nav 6 was advanced without issue and placed successfully.When the filter was to be removed, it could not be retrieved as the bare wire was kinked.Therefore, a 6 fr guiding catheter was advanced and both devices were removed together as one unit.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10838473
• MDR Text Key: 216333559
• Report Number: 2024168-2020-09518
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: 08717648137808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 22440-31
• Device Catalogue Number: 22440-31
• Device Lot Number: 0040161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1