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

Catalog Number	1002703-01
Medical Device Problem Codes	Product Quality Problem (1506); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
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.A visual inspection was performed on the returned guide wire.The reported physical property issue was confirmed.Additionally, it was noted that the ribbon coils were detached from the proximal solder joint and were unraveled.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 similar incidents reported from this lot.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that during an iliac artery intervention, while advancing the 300 cm hi-torque supra core guide wire through the sheath, a sharp section on the coils of the wire outside of the anatomy, was noted.The wire was removed without issue.There was no reported adverse patient effect or a clinically significant delay in the procedure.Another 300 cm supra core was used to complete the iliac intervention.Device analysis revealed that the ribbon coils were detached from the proximal solder joint and were unraveled.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: 8426807
• Report Number: 2024168-2019-02066
• Device Sequence Number: 19345651
• Product Code: DQX
• UDI-Device Identifier: 08717648032998
• UDI-Public: 08717648032998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 1002703-01
• Device Lot Number: 8091961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1