MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
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 mildly tortuous, heavily calcified left anterior descending (lad) artery that is 90% stenosed.Two 014 ht versaturn guide wires were attempted to cross the lesion one after another however; failed due to anatomy.Both tips were noted as kinked.A third 014 ht versaturn guide wire was attempted to cross the lesion but failed due to anatomy and resistance with anatomy was felt during removal.It was noted that the coating peeled but still remained on the guide wire.Another non-abbott guide wire was used to successfully complete the procedure.There was no adverse patient effects or clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular 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.Based on review of the similar incidents, there is no indication of a lot specific issue.There was no damage noted to the guide wire during the inspection prior to use.The investigation determined the reported failure to advance, difficulty to remove and teflon peeling appear to be related to operational circumstances of the procedure.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
• MDR Report Key: 10569934
• Report Number: 2024168-2020-07911
• Device Sequence Number: 2704644
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: 10/31/2021
• Device Model Number: 1013319
• Device Catalogue Number: 1013319
• Device Lot Number: 9111161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1