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

Catalog Number	1012068-09
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
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 difficult to position and the reported detachment were able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.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.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 manipulation/mishandling of the device and/or interaction with the universal flush catheter as an attempt was made to push down and further advance the guide wire resulted in the noted multiple bends on the entire length of the core and ultimately resulted in the reported detachment; thus resulting in the reported difficulty to position and the reported failure to advance.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified lesion in the superficial femoral artery.A ht versacore guide wire was advanced through a universal flush catheter.An attempt to push down and further advance the guide wire to exchange the sheath was made; however, the wire did not advance.It is unknown if the resistance advancing the guide wire was with the anatomy or the universal flush catheter.The guide wire was removed without resistance, but it was noted that the tip separated.The universal flush catheter was removed and the tip of the guide wire was inside the universal flush catheter.The procedure was successfully completed with a new universal flush catheter and a new ht versacore guide wire.There were no adverse patient effects 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: 8034324
• Report Number: 2024168-2018-08421
• Device Sequence Number: 19177321
• Product Code: DQX
• UDI-Device Identifier: 08717648124235
• UDI-Public: 08717648124235
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 11/02/2018

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: 10/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 52