MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING

Catalog Number	1002703-02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
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 evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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.Based on the information reviewed, 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 treat the 100% total occlusion in the right superficial femoral artery (sfa).A supra core guide wire was advanced across the lesion and the lesion was ballooned with a non-abbott balloon dilatation catheter (bdc).The bdc was removed and a drug eluting balloon (deb) was advanced over the supra core guide wire but the deb was unable to cross the transition of the wire.A separation was noted at the transition on the supra core guide wire.The deb was removed from the supra core and a cxi catheter was advanced over the supra core guide wire.The supra core was then removed and a new supra core was advanced.Three new debs were used to complete the procedure.There was no intervention to remove the supra core guide wire.There was no adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6888937
• Report Number: 2024168-2017-07718
• Device Sequence Number: 633676
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: 08717648033001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/22/2017

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: 05/31/2019
• Device Catalogue Number: 1002703-02
• Device Lot Number: 7061561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1