MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE PROCEED GUIDE WIRES; WIRE, GUIDE, CATHETER

Catalog Number	1030904
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the peroneal vessel of the left leg with 90% stenosis, heavy calcification and no tortuosity.The hi-torque (ht) proceed guide wire was advanced with the support catheter and had resistance with the anatomy during advancement when the tip separated in the anatomy.There was resistance with the anatomy during removal, however, there was no force applied.The tip was noted to be stuck in the vessel wall and remained in the patient.There was no attempt in retrieval as the vessel was too small to advance a device.The patient is returning for a by-pass planned earlier on and not due to the separated portion in the anatomy.However, the separated tip will be attempted to be removed during the by-pass surgery.There was no adverse patient sequelae and there was no clinically significant delay 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.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to advance and difficult to remove could not be tested as it was based on operational context.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.The separated portion of the guide wire will be removed during a by-pass surgery.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE PROCEED GUIDE WIRES
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 17650646
• Report Number: 2024168-2023-09485
• Device Sequence Number: 12326488
• Product Code: DQX
• UDI-Device Identifier: 08717648321382
• UDI-Public: 08717648321382
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201834
• 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): 10/02/2023

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: 09/30/2023
• Device Catalogue Number: 1030904
• Device Lot Number: 1100861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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: MEDTRONIC TRAILER BLAZER SUPPORT CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female