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

Catalog Number	1012068-09
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the anatomy and/or other devices resulted in the reported difficulty to remove.Manipulation of the device resulted in the reported stretched coils and ultimately resulted in the reported detachment.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.The additional versacore device referenced is being filed under separate medwatch report.
Event or Problem Description
It was reported that two versacore guide wires were used in the same procedure.Resistance was felt with the anatomy during the removal of both versacore guide wires, and the guide wire tips felt like they were unraveling.Both guide wires were removed from the anatomy as a single unit, and the wire separated into two pieces outside of the patient anatomy.No intervention was required to retrieve the separated portion.Another unspecified guide wire was used to complete the procedure.There was no adverse patient effect and no 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: 8011701
• Report Number: 2024168-2018-08226
• Device Sequence Number: 19187765
• 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): 10/26/2018

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: 8070961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1