MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC*PC2013Y
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received fda medwatch report (b)(4).The event description states: "while removing the fathom wire through the pro great microcatheter, part of the tip of the wire (7-10cm) broke off in the artery and was unable to be removed despite attempt via snare.What was the original intended procedure: y 90 radioembolization.Selective catheterization celiac artery for celiac artery angiogram.Original intended procedure: superselective catheterization of the right hepatic artery for right hepatic artery angiogram and coned beam ct.Cone beam dyna ct with catheter positioned in hepatic arteries with additional 3-d image postprocessing.Transarterial delivering y90 sirshpheres in superselective right hepatic artery.Ultrasound guidance for arterial access.Limited right common femoral artery angiogram and closure device deployment for hemostasis".

• Brand Name: PROGREAT CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 20914171
• Report Number: 2243441-2024-00042
• Device Sequence Number: 15569782
• Product Code: DQO
• UDI-Device Identifier: 04987350727367
• UDI-Public: (01)04987350727367(17)250930(10)231018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/12/2024
• Report Date (Section F): 12/12/2024

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: 09/30/2025
• Device Model Number: MC*PC2013Y
• Device Catalogue Number: MC*PC2013Y
• Device Lot Number: 231018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2024
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• 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: BOSTON SCIENTIFIC FATHOM GUIDEWIRE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/12/2024