MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319J
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
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.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in a bifurcation in the diagonal branch of the left anterior descending (lad) artery.The 014 ht versaturn guidewire was advanced and an unspecified stent was implanted; however, the guide wire became jailed.The guide wire was attempted to be removed; however, was noted to be stretched.A balloon was advanced on the guide wire up to the stent.The guide wire and the balloon were then removed as a single unit.The guide wire was able to be completely removed from the patient.There was no adverse patient sequela and no clinically significant delay reported in the procedure.No additional information was provided.

• 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: 16817652
• Report Number: 2024168-2023-04347
• Device Sequence Number: 15234911
• Product Code: DQX
• UDI-Device Identifier: 08717648198496
• UDI-Public: 08717648198496
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 04/26/2023

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: 1013319J
• Device Catalogue Number: 1013319J
• Device Lot Number: 2112171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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
• Patient Sex: Unknown