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

Catalog Number 22440-31

Device Problems Break (1069); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the left superficial femoral (sfa) artery with moderate calcification, mild tortuosity and 100% stenosis.The emboshield embolic protection system (eps) barewire was being advanced distal to the lesion prior to filter delivery and there was resistance with the non-abbott guiding catheter.The barewire was then removed independently from the non-abbott guiding catheter.However, when the device was removed it was noted that the barewire was caught on the non-abbott guiding catheter.The coils were noted to be unraveled.Nothing was left in the patient and there were no adverse patient effects.A new guiding catheter and a new barewire were used to complete the procedure without issue.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

A visual analysis was performed on the returned device.The reported stretched tip coils were confirmed.The reported break was not confirmed.The reported difficulty advancing and difficulty removing could not be confirmed as it was related to procedural circumstances.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 revealed no other complaints reported from this lot.The investigation determined that the reported difficulty advancing, difficulty removing and stretched coils were likely due to circumstances of the procedure.Based on the reported information and evaluation of the returned unit, it is likely that the non-abbott guiding catheter was bent or kinked resulting in resistance during advancement and difficulty removing causing the tip coils to stretch.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: 17712275
• MDR Text Key: 322979347
• Report Number: 2024168-2023-09786
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22440-31
• Device Lot Number: 3020261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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: TERUMO NAVICROSS GUIDING CATHETER.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 82 KG