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

Model Number	22440-31
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Cardiologist performing a peripheral angiogram, intravascular lithotripsy/stent.A barewire filter delivery wire was being used on this heavily calicified left leg.Barewire fractured with distal tip retention in the popliteal artery.Successful snaring of retained wire.Manufacturer response for temporary carotid catheter for embolic capture, barewire (per site reporter).No response.Made rep [redacted] aware.

• Brand Name: BAREWIRE
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 25425775
• Report Number: 25425775
• Device Sequence Number: 10322497
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808(17)270228(10)4030161(91)3052
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2026
• Report Date (Section F): 05/14/2026

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
• Operator of Device: Health Professional
• Device Model Number: 22440-31
• Device Catalogue Number: 22440-31
• Device Lot Number: 4030161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/14/2026