MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Catalog Number	1013317J
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dragonfly optis imaging catheter was used and after optical coherence tomography (post soft radiopaque portion), the versaturn guide wire was re-advanced on another vessel and could not be advanced.The guide wire was removed independently and noted to have unraveled but intact.Another versaturn guide wire was used to complete the procedure.There was no issue with the dragonfly optis imaging catheter.There was no adverse patient effect 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.
Event or Problem Description
It was reported that the dragonfly optis imaging catheter was used and after optical coherence tomography (post soft radiopaque portion), the versaturn guide wire was attempted to be re-advanced in another vessel and could not be advanced.The guide wire was removed independently and was noted to have unraveled but was still intact.Another versaturn guide wire was used to complete the procedure.There was no issue with the dragonfly optis imaging catheter.There was no adverse patient effect and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was noted upon further review: the guide wire was removed independently and was noted to have unraveled (past soft radiopaque portion) but was still intact.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported break was confirmed.The reported difficult to advance could not be tested due to the device condition.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment nonconformities.The electronic lot history record (elhr) revealed no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties.Analysis of the returned wire noted a core break on the distal end.The stretched coils are likely a result of the core break.Factors that may contribute to a break during use include, but are not limited to, interaction with challenging anatomy, interaction with accessory devices, excessive force, device support, or tensile strength.In this case, the unraveled coils were noted during readvancement of the wire, after it failed to cross the lesion.It is possible that the guide wire sustained damage during readvancement, resulting in the reported difficulty.Manipulation of the wire, when difficulty was encountered, may have contributed to the core break; however, this cannot be confirmed.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: 19037789
• Report Number: 2024168-2024-04226
• Device Sequence Number: 12769833
• Product Code: DQX
• UDI-Device Identifier: 08717648198472
• UDI-Public: (01)08717648198472(17)260131(10)4020871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/14/2024

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: 01/31/2026
• Device Catalogue Number: 1013317J
• Device Lot Number: 4020871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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: DRAGONFLY OPTIS.
• Patient Sex: Unknown