MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Catalog Number	1013319J
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional 014 ht versaturn device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left circumflex (lcx) artery with 90% stenosis, no calcification and mild tortuosity.The versaturn guide wire was used in the lcx and noted to have stretched and got caught on the stent's strut during removal.Another versaturn guide wire was used to treat the obtuse marginal (om) and had stretched coils probably from the first guide wire.The guide wires were removed independently.It was noted on both versaturn guide wires that the core and coils were not intact.The versaturn guide wire used in the lcx was noted to possibly have fragments of coil on the versaturn guide wire used in the om.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 stretched coils were confirmed.The reported break could not be confirmed.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.In this case, the procedure was using two guide wires, one in the left circumflex artery (lcx) and the reported wire was used in the obtuse marginal (om).It was reported that the guide wire used in the lcx likely interacted with the reported guide wire, resulting in the reported stretched/damaged coils.Additionally, return analysis noted that there was no coil break or separation as reported.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17732909
• Report Number: 2024168-2023-09970
• Device Sequence Number: 6411459
• Product Code: DQX
• UDI-Device Identifier: 08717648198496
• UDI-Public: 08717648198496
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141782
• 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): 11/02/2023

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: 02/28/2025
• Device Catalogue Number: 1013319J
• Device Lot Number: 3030971
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 85 KG