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

Catalog Number	1020010
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
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 not returned for analysis.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement resistance was met with the moderately tortuous, moderately calcified and 99% stenosed anatomy resulting in the reported failure to advance.Interaction with the moderately tortuous, moderately calcified and 99% stenosed anatomy during removal resulted in the reported difficult to remove.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 de novo, concentric lesion in the distal right coronary artery with moderate tortuosity, moderate calcification and 99% stenosis.A hi-torque turntrac flex guide wire was advanced; however, failed to cross the lesion due to the patient anatomy.Resistance was also met with the anatomy on removal of the guide wire as an independent unit.The procedure was successfully continued with a non-abbott guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.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: 8386888
• Report Number: 2024168-2019-01630
• Device Sequence Number: 11323291
• Product Code: DQX
• UDI-Device Identifier: 08717648222641
• UDI-Public: 08717648222641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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: 05/31/2020
• Device Catalogue Number: 1020010
• Device Lot Number: 8060561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATH: HYPERION 6FR1.0
• Patient Age: 61 YR
• Patient Weight: 58