MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM

Catalog Number	1012068-09
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
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.The reported stretched coils was able to be confirmed.The reported break was unable to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment, as it was based on operational circumstances.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reported difficulties appear to be related to circumstances of the procedure as it is likely that as the guide wire was withdrawn resistance was met with the anatomy resulting in the reported difficulty to remove.Manipulation of the device resulted in the reported/noted stretched coils.A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.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 carotid artery.There was resistance with the anatomy while withdrawing the versacore guide wire, and the coil felt like it was stretching and that the tip and wire had disconnected.Upon removal from the patient anatomy, the guide wire tip was noted to be separated, but was not in two pieces.The guide wire was fully retrieved from the patient, and another unspecified guide wire was used to complete the procedure.There was no reported adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7997013
• Report Number: 2024168-2018-08107
• Device Sequence Number: 10835193
• Product Code: DQX
• UDI-Device Identifier: 08717648124235
• UDI-Public: 08717648124235
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K083706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: 06/30/2020
• Device Catalogue Number: 1012068-09
• Device Lot Number: 8071061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1