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

Catalog Number	1020010
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2018
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.Guide wire: floppy xience prox 3.5x18.Evaluation summary: the device was returned for analysis with the proximal coils separated.The reported stretched was able to be confirmed.The reported difficult to position was unable to be replicated in a testing environment due to the condition of the returned device.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.After the procedure, manipulation of the device and/or packing for return analysis resulted in the reported/noted separated proximal coils, detached proximal adhesive transition and the noted kinked core.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 to treat a de novo lesion in a mildly calcified proximal left anterior descending artery (lad) that did not have any tortuosity.A 190 cm turntrac guide wire was advanced to the lesion and an unspecified stent was implanted.Then, an unspecified floppy guide wire was inserted in a bifurcation branch.An attempt was then made to advance a 3.5 x 18 mm xience prox stent delivery system (sds) to the lesion; however, the sds was not able to advance over the turntrac guide wire.It was thought that the solder part was damaged.The floppy guide wire was then removed; however, the sds was still not able to advance over the turntrac guide wire.It was also noted that the coils of the guide wire were stretched.It was reported that the stretched coils could have occurred when the guide wire was inserted inside the anatomy and that it was not caused by the xience prox sds.The turntrac guide wire was then replaced with an another unspecified turntrac guide wire, and the same sds was able to advance over it to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Analysis of the returned device revealed that the proximal coils were separated as the proximal adhesive transition was not present.It was reported that there was no foreign material left inside the anatomy.

• 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: 8075874
• Report Number: 2024168-2018-08851
• Device Sequence Number: 1693167
• Product Code: DQX
• UDI-Device Identifier: 08717648222641
• UDI-Public: 08717648222641
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/15/2018

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: 04/30/2020
• Device Catalogue Number: 1020010
• Device Lot Number: 8050261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1