MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the stiff glidewire involved (3-4cm), broke off into the patient.The tip was attempted to be removed for two hours, but the tip went into a branch off the profunda and was left in the patient.The branch off was tied to ensure that the part of the wire could only go distal and not cause any harm to the patient.The doctor did not perform the endovascular iliac recanalization (evar) procedure as intended due to the wire break.The doctor had to perform a cutdown, about 6 inches on the left leg, to access the broken piece of wire.The procedure was started with left groin access via a 6 fr sheath, a 5 fr vs1 catheter, and the stiff glidewire involved in the catheter.The doctor went up and over the iliac occlusion, the doctor was burrowing the wire in the occlusion.When the doctor could not pass the occlusion, he removed the wire and noticed the tip was missing.A fluoroscopy was performed and the branch of the profunda was seen.The patient was fine.There was no atherectomy device or laser used.There was no metal introducer or dilator used.There was no excessive torque.The procedure outcome was not successful.There was no equipment or other devices used with the above product.Additional information was received on 14 apr 2022: terumo medical received a user facility medwatch report (b)(4).The event description states: "during the procedure, the wire fractured off the stiff angled glide which embolized to the left profunda.Original intended procedure was an endovascular iliac recanalization.".

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 14192637
• Report Number: 2243441-2022-00015
• Device Sequence Number: 4446865
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2022
• Report Date (Section F): 04/25/2022

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 210914
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2022
• 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: 5 FR VS1 CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/25/2022