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

Catalog Number	1044592
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 difficulty to position was able to be confirmed.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.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.It is likely that the guide wire and microcatheter were not coaxially aligned.Interaction with the microcatheter, as the guide wire was advanced, resulted in the noted device damages (bent/kinked core, misaligned and separated coils) and ultimately resulted in the reported difficulty to position.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 performed to treat a lesion in an unspecified artery.During the procedure, the powerturn guide wire got stuck in microcatheter.A new guide wire was used successfully to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.Return device analysis revealed that the coil was separated, 3.2 cm proximal to the center solder with the core intact.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: 8016447
• Report Number: 2024168-2018-08241
• Device Sequence Number: 1381654
• Product Code: DQX
• UDI-Device Identifier: 08717648173936
• UDI-Public: 08717648173936
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/29/2018

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 Catalogue Number: 1044592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1