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	12/09/2024
Type of Reportable Event	Serious Injury
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.Based on the information provided, a definitive cause for the reported tip separation could not be determined.Factors that may contribute to material separation resulting in unexpected medical intervention include, but are not limited to, anatomical conditions, damaged during positioning, interaction with associated devices, excessive force during removal, or entrapment within the vessel.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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa).The 315 cm barewire was used with an emboshield nav 6 device.The emboshield was used successfully in the procedure without issue; however, after removal the tip and coil of the barewire were noted to have separated in the patient.Therefore, a snare was used to remove the separated tip and coil.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 21037309
• Report Number: 2024168-2024-15404
• Device Sequence Number: 8538831
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808(17)270131(10)4020661
• 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
• Report Date (Section B): 12/30/2024

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: 4020661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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: EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown