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

Catalog Number	1002703-02
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and dimensional inspections were performed on the returned wire.The reported wire separation was confirmed.The reported difficult to remove 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 similar incidents reported from this lot.The investigation determined the reported difficulty to remove and separation appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The prostar device is filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the aorta artery.A hi-torque supra core guide wire was advanced and a prostar was advanced over the guide wire.The guide wire was backed up and the sutures were placed using a pre-close technique.The guide wire was re-advanced and during removal of the prostar device resistance with the guide wire was felt.The procedure was performed and the prostar sutures were used successfully to close the access site.A femoral angiogram was performed and it was noted that the guide wire had separated and the tip was 3cm from the access site.A cut-down was performed to remove the separated guide wire tip and the patient is fine.There was no adverse patient sequela and no 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: 8626085
• Report Number: 2024168-2019-03955
• Device Sequence Number: 1924871
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: 08717648033001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1002703-02
• Device Lot Number: 7082562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention