MAUDE Adverse Event Report: AV-TEMECULA-CT 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE

Catalog Number	1020010
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
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.The device was returned for analysis.The reported prolapse was unable to be replicated in a testing environment; however, intermittent pieces of teflon coating were noted on the coils.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.Interaction with other devices during removal (torque device, rhv) resulted in the noted intermittent pieces of teflon coating.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that during a procedure of the moderately tortuous, heavily calcified, 80% stenosed, de novo, mid right coronary artery (rca), after 3.0 x 38 mm non-abbott stent implantation and balloon dilatation, the turntrac guide wire was noted to be prolapsed at a saphenous vein graft (svg).A different non-abbott guide wire was advanced next to the turntrac and a microcatheter used as a support to retrieve the turntrac.The device was successfully removed from the vessel.There was no reported adverse patient effect or a clinically significant delay in procedure.A non-abbott guide wire was used to complete the procedure.Return device analysis revealed intermittent scraped and flaked teflon coating noted on the coils.No additional information was provided.

• Brand Name: 0.014 HI-TORQUE (HT) TURNTRAC 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: 7807315
• Report Number: 2024168-2018-06519
• Device Sequence Number: 19216355
• Product Code: DQX
• UDI-Device Identifier: 08717648222641
• UDI-Public: 08717648222641
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: 03/31/2020
• Device Catalogue Number: 1020010
• Device Lot Number: 8040461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1