MAUDE Adverse Event Report: AV-TEMECULA-CT HT VERSATURN GUIDE WIRE

Catalog Number	1013319
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported peeling was confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.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 from this lot.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that as the guide wire was advanced interaction with the moderately tortuous and moderately calcified anatomy resulted in the reported failure to advance.Interaction with the copilot and/or other devices as the device was being removed resulted in the reported peeled/noted scrapped teflon coating.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It reported the procedure was performed to treat a lesion with moderate tortuosity and moderate calcification in the right coronary artery (rca).The versaturn guide wire was advanced but met resistance with the anatomy.When the guide wire was removed, there were green pieces of coating remaining in the copilot.The copilot was flushed and flakes of green teflon came out.There was some green teflon missing 30 mm in length half way down the guide wire.There was no resistance noted between the copilot and the guide wire.It was confirmed that no teflon entered into the patient vasculature.The copilot was used with a new balance middleweight (bmw) guide wire to complete the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7793464
• Report Number: 2024168-2018-06330
• Device Sequence Number: 19155798
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 05/31/2020
• Device Catalogue Number: 1013319
• Device Lot Number: 8061561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR