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

Catalog Number	1020014
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
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 with the core and coils separated.The reported stretched coils were able to be 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 difficulties appear to be related to circumstances of the procedure.Manipulation and/or interaction with the anatomy and/or other devices resulted in the reported stretched coils.The noted core and coil detachments occurred due to handling after pulling back the turntrac out of the guiding catheter.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 lesion located in the distal, narrow, right coronary artery.After a failed attempt to cross due to the anatomy, the hi-torque turntrac guide wire was removed.Outside the patient, it was noticed that the coils were stretched.The core did not separate.The procedure was continued with a whisper guide wire.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.Device analysis revealed the core and tip coils wer separated.Follow-up confirmed the core separated outside the patient after pulling back the turntrac out of the guiding catheter.The physician observed the damaged coils and then it broke.

• 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: 8241097
• Report Number: 2024168-2019-00300
• Device Sequence Number: 11152467
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: 08717648222726
• 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): 01/11/2019

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: 07/31/2020
• Device Catalogue Number: 1020014
• Device Lot Number: 8081361
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1