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

Model Number	22440-31
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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.
Event or Problem Description
It was reported that the procedure was to treat the right superficial femoral artery (sfa).During the procedure, the emboshield nav6 embolic protection system (eps) was used and was retrieved without issue.The barewire was left in place and a 5fr guide catheter (gc) was advanced over the barewire.When the barewire was pulled resistance was felt with the gc and the coil on the barewire separated in the sfa.The separated tip was snared.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The reported material separation was confirmed.The reported difficulty removing could not be confirmed as it was related to circumstances of the procedure.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.Based on the reported information and analysis of the returned device, the reported difficulty removing, and material separation was likely due to interaction with the guiding catheter during removal, resulting in separation and unexpected medical intervention to snare the separated tip.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: 19643785
• Report Number: 2024168-2024-07831
• Device Sequence Number: 15391313
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808(17)261231(10)4010361
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 4010361
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: GLIDECATH 5FR, 100CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown