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); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with heavy calcification.The barewire workhorse 315 guide wire was advanced with resistance due to the anatomy and the tip of the guide wire separated in the common femoral artery.A snare device was used to remove the separated tip.Another unspecified guide wire was used to complete the procedure.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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.In this case, it is likely that anatomical conditions contributed to the reported failure to advance and while advancing against resistance, the tip pf the barewire separated resulting in unexpected medical intervention to retrieve the separated portion of the wire.Based on the reported information, there is no indication that the reported failure to advance and material separation resulting in unexpected medical intervention is related to 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: 20089370
• Report Number: 2024168-2024-10200
• Device Sequence Number: 20786260
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808(17)260531(10)3060562
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/28/2024

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 Expiration Date: 05/31/2026
• Device Model Number: 22440-31
• Device Catalogue Number: 22440-31
• Device Lot Number: 3060562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown