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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received a user facility (b)(4).The event description states: "a small part of a guidewire broke off inside the patient's leg.What was the original intended procedure? : ultrasound-guided access of the right common femoral artery, largest sheath 6 fr.2.Introduction of catheter into aorta 3.Left pelvic angiogram with radiologic supervision and interpretation 4.Left lower extremity angiogram with radiologic supervision and interpretation 5.Left dorsalis pedis access under ultrasound guidance, 4 fr 6.Selective catheterization of superficial femoral artery and popliteal artery with balloon angioplasty (3.0, 4.0 and 5.0 serranator balloon, and stenting (5mm x 120mm + 5mm x 120mm + 5mm x 40mm, + 5mm x 60mm everflex protege bm from distal common femoral artery to above knee popliteal artery) 7.Selective catheterization of left profunda femoris with balloon angioplasty (5mm x 7.Left external iliac artery balloon angioplasty (5mm x 40mm armada balloon) 8.Right common femoral artery closure with angioseal closure device." additional information was received on 03 feb 2023: when the handles on the clip appliers were squeezed the clip applier jammed.A clip did not feed, the handles were stuck and would no longer open.

• 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: 16418876
• Report Number: 2243441-2023-00006
• Device Sequence Number: 5742375
• Product Code: DQX
• UDI-Device Identifier: 04987350714763
• UDI-Public: 04987350714763
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2023
• Report Date (Section F): 02/22/2023

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 Model Number: N/A
• Device Catalogue Number: GA1830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2023
• 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: 3.0, 4.0 AND 5.0 SERRANATOR BALLOON; 5MMX40MM ARMADA BALLOON; 6 FR CATHETER; ANGIO-SEAL; EVERFLEX PROTEGE; STENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 02/22/2023