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); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed in the right internal carotid artery with mild calcification.The barewire workhorse 315 was used with the emboshield nav 6 embolic protection system(eps) as a longer guide wire was needed for the procedure.The barewire and eps were advanced to their intended location and then a non-abbott balloon was advanced with slight resistance with the barewire and eventually got stuck.An attempt was made to remove the balloon from the barewire, but significant resistance was noted.Therefore, the barewire, filter and balloon were all removed as a single unit.Another emboshield nav 6 was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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.The reported difficulties appear to be related to circumstances of the procedure.There was no difficulty reported advancing the barewire and eps to their intended location.Reportedly, resistance was encountered when the non-abbott balloon was advanced, and the devices eventually got stuck.It is likely that during advancement of the non-abbott balloon catheter, damage or kinks to the barewire and/or balloon catheter occurred causing resistance and untimely resulting in the devices getting stuck together.Based on the results of the complaint investigation, 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: 21529848
• Report Number: 2024168-2025-02355
• Device Sequence Number: 18226478
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808(17)251231(10)3010661
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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 Expiration Date: 12/31/2025
• Device Model Number: 22440-31
• Device Catalogue Number: 22440-31
• Device Lot Number: 3010661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2023
• 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: EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM(EPS).
• Patient Sex: Unknown