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

Catalog Number 22445-31

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2023

Event Type  malfunction  

Event Description

It was reported that the procedure to treat a lesion in the popliteal artery.The barewire guidewire (gw) was used with a non-abbott atherectomy device; however, the barewire became tangled with the atherectomy device and the distal tip of the barewire became twisted.The barewire was remove with the atherecotomy device as a single unit.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 complaints reported from this lot.Based on the information provided, the difficulty removing, and subsequent twisting of the barewire tip appears to be due to circumstances of the procedure.It is likely that clearance between the inner diameter of the non-abbott atherectomy device and outer diameter of the barewire became reduced during use, resulting in the devices becoming stuck together causing difficulty to remove and resulting in twisting of the barewire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 16517990
• MDR Text Key: 311044970
• Report Number: 2024168-2023-02473
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22445-31
• Device Lot Number: 1111661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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
• Treatment: JETSTREAM ATHERECTOMY DEVICE
• Patient Age: 59 YR
• Patient Sex: Male