MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH; WIRE, GUIDE, CATHETER

Model Number	25-5011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a prostatic artery embolization (pae) procedure using an izanai wire, bilateral spasm in the target arteries was recognized.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• MDR Report Key: 20579450
• Report Number: 2243441-2024-00031
• Device Sequence Number: 18349819
• Product Code: DQX
• UDI-Device Identifier: 04987350734662
• UDI-Public: (01)04987350734662(17)260531(10)230607
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial
• Report Date (Section B): 10/29/2024
• Report Date (Section F): 10/31/2024

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: 05/31/2026
• Device Model Number: 25-5011
• Device Catalogue Number: TW*AS418XH
• Device Lot Number: 230607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/02/2024
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Date Report Sent to FDA: 10/31/2024