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

Model Number	1030904
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
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 treat a lesion in the right tibial peroneal trunk with 100% stenosis, heavy calcification and heavy tortuosity.The hi-torque (ht) proceed guide wire failed to cross due to the anatomy and about 1cm of the tip separated inside the patient.There was no resistance during removal.There was no attempt to retrieve the separated portion and a stent was later implanted to crush the separated tip in the vessel.Another ht command 14 es guide wire was used to complete the procedure without issues.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.The separated portion of the guide wire was embedded in the vessel.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9 - device available for evaluation updated from ¿yes¿ to ¿no¿.

• 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: 17326122
• Report Number: 2024168-2023-07544
• Device Sequence Number: 5536889
• Product Code: DQX
• UDI-Device Identifier: 08717648321382
• UDI-Public: 08717648321382
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 10/31/2024
• Device Model Number: 1030904
• Device Catalogue Number: 1030904
• Device Lot Number: 2111461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Hispanic
• Patient Race: White