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

Catalog Number	1012068-07
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
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 and complaint history could not be conducted because the lot number was not provided.It is possible that a coagulation of blood and/or contrast on the guide wire resulted in the reported difficulty to position and the reported difficulty to remove; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported in a general comment made by the physician that during previous use of the ht versacore modified j 300 cm guide wires, unspecified stents and balloons have had difficulty advancing over the wire as well as difficulty being removed from the wire.They seem to be sticking to the guide wire.There were no issues with advancement or removal of the guide wire itself.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number: (b)(4).Date of event was an estimate.

• 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: 8652471
• Report Number: 2024168-2019-04196
• Device Sequence Number: 14262062
• Product Code: DQX
• UDI-Device Identifier: 08717648124211
• UDI-Public: 08717648124211
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 05/30/2019

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 Catalogue Number: 1012068-07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1