MAUDE Adverse Event Report: AV-TEMECULA-CT HT POWERTURN FLEX; GUIDE WIRE

Catalog Number	1044592
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis.The reported peeling was able to 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 identified no other similar incidents from this lot.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other powerturn flex device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the diagonal artery with no tortuosity and no calcification.Two 190cm powerturn flex guide wire (gw) were advanced to the target lesion together with an unspecified guiding catheter.An unspecified balloon catheter was advanced to the target lesion and dilatation was performed.The gw was removed, and the balloon was deflated; however, fluoroscopy showed a piece of coil was caught in the tip of the guiding catheter.The gw was inspected, and it was observed that a piece of the coil was missing from the tip of the gw.No resistance was felt during advancement or removal of the gw.The detached coil was snared from the tip of the guiding catheter.Then the guiding catheter was removed.The procedure was successfully completed with unspecified devices.There was no adverse patient sequela reported.No additional information was provided.Additionally, device analysis noted a second powerturn flex guide wire returned with scrapped teflon noted on the core.The account confirmed that the second powerturn flex was used in the procedure and that it is possible that the scrapping happened in the patient.The wire was placed behind the stent to hold the location and when the wire was removed the stent could have scrapped it.No additional information was provided.

• Brand Name: HT POWERTURN FLEX
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8732519
• Report Number: 2024168-2019-05067
• Device Sequence Number: 1787980
• Product Code: DQX
• UDI-Device Identifier: 08717648173936
• UDI-Public: 08717648173936
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112957
• 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): 06/25/2019

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: 07/31/2020
• Device Catalogue Number: 1044592
• Device Lot Number: 8080761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other