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

Catalog Number	1010480-HJ
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
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 2.0 x 12 mini trek device referenced is being filed under a separate medwatch report.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.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 the procedure was to treat a de novo lesion located in the mid-left anterior descending coronary artery that was mildly tortuous, mildly calcified and 80% stenosed.The lesion was crossed with a hi-torque pilot 50 guide wire.The mini trek rx 2.0 x12 mm balloon dilatation catheter (bdc) crossed and the lesion was pre-dilated, however, during withdrawal of the bdc, resistance was met with the guide wire and it was removed with difficulty.A non-specified stent delivery system was advanced but it could not cross lesion because of resistance with the guide wire.The guide wire was removed and the coating of the pilot 50 was found to have a sticky feeling.There was a delay in the procedure, however, it was not clinically significant as it was stated there were no patient effects.No medication was given to the patient due to an issue with the use of the device.Another device was used to complete the procedure.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: 8126562
• Report Number: 2024168-2018-09236
• Device Sequence Number: 244354
• Product Code: DQX
• UDI-Device Identifier: 08717648073861
• UDI-Public: 08717648073861
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K060449
• 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): 12/03/2018

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: 07/31/2020
• Device Catalogue Number: 1010480-HJ
• Device Lot Number: 8080771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1