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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the wire was being used to cross the superficial femoral artery (sfa) from left antegrade approach.While pushing the wire it snapped around 20cm from the tip.The patient had 5fr micro puncture access.The wire was inserted through the micro access sheath.The patient was undergoing surgery to remove the wire left in the body.The doctor said that he was pushing and pulling in attempt to cross down bypass graft.Anatomy looked to be normal from common femoral artery (cfa) to mid superfical femoral artery (sfa).Severe pad noticed from mid superfical femoral artery (sfa) to distal bypass graft.Patients pre-procedural condition was peripheral artery disease (pad) diagnosis with occluded bypass graft.The doctor had to perform open removal of the broken wire.Relevant tests and lab results were an angiogram on (b)(6) 2023.Type of procedure being performed was a left antegrade approach angiogram with thrombolysis.The estimated blood loss was less than 250cc.Addtional information was received on 18aug2023: the patient was stable and foreign body removal surgery went well.Guidewire tip was successfully removed from the patient.An open surgical foreign body removal through was performed.Xray was performed to confirm the tip of the wire was removed from the patient.It was seen on xray and other half of wire did not hydrophilic piece of the wire.

• 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: 18275080
• Report Number: 2243441-2023-00051
• Device Sequence Number: 3177136
• Product Code: DQX
• UDI-Device Identifier: 04987350717924
• UDI-Public: 04987350717924
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/06/2023
• Report Date (Section F): 12/06/2023

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 Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: GA1430
• Device Lot Number: 230220A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2023
• 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: VASCULAR SOLUTION 5FR STIFF MICRO PUNCTURE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 12/06/2023