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

Model Number	22440-31
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to a 95% stenosed lesion in the right superficial femoral artery with heavy calcification.The 315 cm barewire was loaded onto the large emboshield nav6 embolic protection system (eps) and advanced to the intended location.A non-abbott atherectomy device was then advanced on the barewire and used in the procedure; however, the atherectomy device was noted to have low stream.Therefore, the physician attempted to remove the atherectomy device from the barewire; however, during removal the atherectomy device continue to torque causing the barewire to separate.The atherectomy device and the proximal barewire were removed as a single unit.Enough of the barewire that remained in the patient was exposed to advance the retrieval catheter and removed the eps filter without issue.Unspecified balloon dilatation and unspecified stent implantation were used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
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 a 95% stenosed lesion in the right superficial femoral artery with heavy calcification.The 315cm barewire was loaded onto the large emboshield nav6 embolic protection system (eps) and advanced to the intended location.A non-abbott atherectomy device was then advanced on the barewire and used in the procedure; however, the atherectomy device was noted to have low stream.Therefore, the physician attempted to remove the atherectomy device from the barewire; however, during removal the atherectomy device continue to torque causing the barewire to separate.The atherectomy device and the proximal barewire were removed as a single unit.Enough of the barewire that remained in the patient was exposed to advance the retrieval catheter and removed the eps filter without issue.Unspecified balloon dilatation and unspecified stent implantation were used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.Production record and corrective and preventative 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.Based on the reported information and evaluation of the returned product, the tip separation likely occurred due to interaction with the non-abbott atherectomy device.It is likely that the barewire was subjected to torsional loads exceeding the material limitations causing the tip to separate.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 21732265
• Report Number: 2024168-2025-03251
• Device Sequence Number: 4147845
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808(17)270831(10)4090461
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/06/2025

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: 4090461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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: JET STREAM ATHERECTOMY SYSTEM; LARGE EMBOSHIELD NAV6 EPS
• Patient Sex: Male
• Patient Race: Black Or African American