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.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.History investigation of the product with the involved product code/lot number · no anomaly was found in the manufacturing record and the shipping inspection record.· no other similar report was found in the past.Udi no.(b)(4).(cause of occurrence).Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual sample was not returned and investigation of it could not be performed, it was not possible to clarify the cause of occurrence.(countermeasure) ashitaka factory assures the quality of this product by performing following work and inspections.The outer diameter of product is controlled.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as deformation.Ifu of this product includes the following warning: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.For importer report please see registration no.2243441-2024-00031.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20579586
• Report Number: 9681834-2024-00186
• Device Sequence Number: 15510634
• 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
• PMA/510(K) Number: K063695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 98 KG