MAUDE Adverse Event Report: ABBOTT VASCULAR INC. BAREWIRE; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number	22440-31
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right common iliac artery (cia).After the left common femoral artery was punctured, the barewire guide wire was advanced however the aortoiliac bifurcation was too steep therefore it was difficult to advance the wire.The nav6 embolic protection system (eps) delivery catheter was advanced over the barewire however resistance was met.After attempting to advance for 5-10 minutes, a kink was noted to the delivery catheter.The delivery catheter along with the barewire was retracted with resistance.Once outside the anatomy it was noted the delivery catheter and the barewire had separated and a portion remained in the body.A snare device was used to remove the separated portion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional analysis was performed on the returned device.The reported material separation was confirmed.The reported difficulty to advance and difficult to remove were unable to be confirmed as it was based on circumstances of the procedure due to anatomical conditions.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The investigation determined that the reported difficulties were due to circumstances of the procedure.The reported difficulty to advance was likely due to anatomical conditions as it was reported that the aortoiliac bifurcation was too steep.It is likely that during the attempt to advance over the steep bifurcation, the emboshield delivery cather and barewire kinked preventing further advancement.Additionally, with the delivery catheter and barewire kinked, resistance was encountered during removal and the delivery catheter and barewire separated at the kink.As a result, unexpected medical intervention was required to remove the separated portion of the delivery catheter and barewire with a snare device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: BAREWIRE
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20007913
• Report Number: 2024168-2024-09768
• Device Sequence Number: 7257714
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808(17)270331(10)4040361
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K191173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 22440-31
• Device Catalogue Number: 22440-31
• Device Lot Number: 4040361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown