MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE PILOT GUIDE WIRE

Catalog Number	1010482-H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
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 identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the guide wire and guiding catheter were not coaxially aligned; thus interaction with the guiding catheter as the guide wire was advances resulted in the reported difficulty to position and the reported peeling of the coating.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that during a procedure of the mildly tortuous, heavily calcified, concentric, 99% stenosed, distal right coronary artery (rca) two different non-abbott guide wires (gw) were used separately but failed to cross the lesion.A pilot gw was used but met resistance inside the guide catheter and was removed; outside the anatomy peeling of the coating was suspected.A different gw was used to complete the procedure without reported issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the initial medwatch report filed, additional information was received stating that there was no peeled coating.No additional information was provided.

• Brand Name: HI-TORQUE PILOT 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: 7388657
• Report Number: 2024168-2018-02371
• Device Sequence Number: 1007727
• Product Code: DQX
• UDI-Device Identifier: 08717648073892
• UDI-Public: 08717648073892
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: 08/31/2019
• Device Catalogue Number: 1010482-H
• Device Lot Number: 7091871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1