MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE ADVANTAGE TRACK; WIRE, GUIDE, CATHETER

Model Number	RA*GB14301C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the during a trial of the new glidewire advantage track wires, one of the.014 wires snapped off inside the patient after one pass.The wire snapped at the joint and put a screeching halt to the case.The patient's condition was stable and okay, the procedure outcome was a success.Additional information was received on 16jan2020.It was a peripheral intervention/cli case.The wire entered the patient through a 4/5 slender sheath in the posterior tibial artery.The wire was located and still is in the patient's posterior tibial artery; the wire was not retrieved.The doctor had to gain access in a different vessel (the anterior tibial) and finished the case via that access site.The wire breaking off in the posterior tibial artery changed what his whole game plan was for intervention.The patient was not hospitalized for a longer period.Additional information was received on 20jan2020.The patient had stenosis and calcification.The patient was reported to be fine and the case was able to be completed successfully.The length of the wire remained inside the patient was 40mm (4cm).The wire snapped approximately 4cm from the distal tip of the wire.The doctor uses a technique where he loops the wire, then pushes and twists the wire to cross lesions.It is a very common tactic he uses to cross tight lesions.This time, he looped the wire one time, pushed the wire forward, while twisting at the same time and advanced the wire through the lesion.After he passed the lesion, almost immediately upon "undoing" the loop he had previously created, the distal 4cm of the wire snapped off in the patient's posterior tobias artery.This was a setback in the case because it shut down the patient's posterior tibial artery and caused the doctor to have to use a different access site to complete the case.Once the wire snapped, the doctor was unable to complete the case from the pt artery.He had to gain access in the patient's anterior tibial artery in order to proceed.It was not a favorable location to complete the case from.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE TRACK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9664528
• Report Number: 2243441-2020-00007
• Device Sequence Number: 16268854
• Product Code: DQX
• UDI-Device Identifier: 04987350727886
• UDI-Public: 04987350727886
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2020
• Report Date (Section F): 02/04/2020

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: 10/31/2021
• Device Model Number: RA*GB14301C
• Device Catalogue Number: GAT1430
• Device Lot Number: 191103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2020
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2020
• 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: Other
• Patient Age: 66 YR
• Patient Weight: 74
• Date Report Sent to FDA: 02/04/2020