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

Catalog Number	1012068-07
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2018
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 armada 35 referenced is being filed under a separate medwatch report number.Evaluation summary: the device was returned for analysis.The reported difficult to position and difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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 as it is likely that interaction with the moderate to heavily tortuous, 100% stenosed anatomy as the guide wire was advanced resulted in the noted multiple sporadic core kinks and bends thus as the 4 x 150 mm armada 35 catheter was advanced resulted in the reported difficult to position and the reported difficult to remove.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 to the moderate to heavily tortuous, 100% stenosed, proximal to distal right superficial femoral artery (rsfa).After placement of a hi-torque (ht) versacore guide wire, a 4 x 150 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced, but met resistance with the guide wire and was only able to reach the proximal rsfa.The balloon of the pta catheter was inflated and deflated with no issues noted.During removal of the pta catheter from the anatomy, it again met resistance and became stuck on the guide wire.A non-abbott guide wire was placed to serve as a buddy wire so access was not lost and the ht versacore guide wire & armada pta catheter were removed from the anatomy as a unit.The procedure was completed with the successful stenting of the complete rsfa.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.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: 7386990
• Report Number: 2024168-2018-02364
• Device Sequence Number: 10822494
• Product Code: DQX
• UDI-Device Identifier: 08717648124211
• UDI-Public: 08717648124211
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018

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: 10/31/2019
• Device Catalogue Number: 1012068-07
• Device Lot Number: 7110961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 64