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

Model Number	1030003J
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery with 80% stenosis, moderate calcification and heavy tortuosity.The hi-torque (ht) infiltrac guide wire crossed the lesion, however, the guide wire had exposed a thin wire like piece in the proximal end and unraveled.The guide wire started to coil around the proximal end not allowing any device to cross over it.The core of the guide wire is in one piece, however, it is unknown if the coils detached from the core of the guide wire.A guide liner was not used.Another guide wire 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
A visual inspection was performed on the returned device.The reported break could not be confirmed; however, the material deformation (coils) noted during return analysis was likely reported as a break.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 was unable to determine a conclusive cause for the reported break.In this case, it is possible that the guide wire interacted with the patient¿s moderately calcified, heavily tortuous, and 80% stenosed lesion during advancement, resulting in the reported material deformation (coils) and stretched coils; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE INFILTRAC 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: 15473187
• Report Number: 2024168-2022-09960
• Device Sequence Number: 3051064
• Product Code: DQX
• UDI-Device Identifier: 28717648233719
• UDI-Public: 08717648233715
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K193126
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 03/31/2024
• Device Model Number: 1030003J
• Device Catalogue Number: 1030003J
• Device Lot Number: 2040561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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
• Patient Sex: Unknown