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

Catalog Number	1002703-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual and dimensional inspection was performed on the returned guide wire.The separation was confirmed.The resistance was unable to be confirmed as it was based on case circumstances.The investigation determined that the reported difficulty was related to case circumstances.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 of the reported lot revealed no other similar incidents.It should be noted that the ht supra core instruction for use states: guide wires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage.Do not use damaged wires.Using a damaged wire may result in vessel damage and/or inaccurate torque response.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that a hi-torque supra core guide wire was inserted into a 6f sheath with no complications.The 6f sheath was removed and a dilator was advanced when resistance was felt with the guide wire.The dilator and guide wire were being removed when resistance was felt.After removal it was noticed that the guide wire was frayed.The frayed part was removed and the guide wire was re-inserted into a non-abbott device; however, it could not advance.The procedure was successfully completed with a new hi-torque supra core guide wire.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Return device analysis confirmed that the guide wire was separated.

• 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: 6139462
• Report Number: 2024168-2016-08488
• Device Sequence Number: 10776260
• Product Code: DQX
• UDI-Device Identifier: 08717648032998
• UDI-Public: (01)08717648032998(17)180731(10)6082361
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 1002703-01
• Device Lot Number: 6082361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2016
• Initial Report FDA Received Date: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6F
• Patient Age: 88 YR