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

Model Number	RF*GA35353P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Mechanism of the break of the guidewire terumo ashitaka factory is aware that the guidewire may be broken off when it has been subjected to one of the following loads described below, and the broken section of the core wire presents some regularity depending on the load the guidewire has been subjected to.Repetitive bending load at a 90-degree angle; dimple pattern is observed on the broken surface of the core wire.No tapered deformation is observed on the broken end.One-way continuous torque load to a bent guidewire; radial streaks are observed on the broken surface of the core wire.Pulling load in one direction; the broken end of the core wire has been tapered.Pulling load to a guidewire kept in a loop; the broken end of the core wire has been curved.A review of the device history record and the product release judgement record of the invovled product code/lot# combination was conducted with no findings.Ifu states: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire m and/or the catheter and determine the cause by fluoroscopy.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.Do not apply repetitive bending force to one specific point of the device as this may cause damage to the giidewire m.It is likely that the actual sample was broken off due to having been subjected to one of the loads described above.However, with no return of the actual device the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr 2243441-2020-00069 for the importer report.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the involved radifocus was used during the procedure.Part of the wire broke off in the patient during the procedure.They had to bring the patient back the next day to remove the broken piece.Additional information was received on 06jan2021.The procedure was a left upper extremity venogram.Angle glide wire 0.035 extravasated outside the vein with persistent twisting of the wire; the wire became caught an extra vascular tissue as the user tried to pull the wire the tip of it severed off.The user does not believe there was any issue with the wire itself.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11193469
• Report Number: 9681834-2020-00277
• Device Sequence Number: 19772188
• Product Code: DQX
• UDI-Device Identifier: 04987350726421
• UDI-Public: 04987350726421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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: 03/31/2022
• Device Model Number: RF*GA35353P
• Device Catalogue Number: GR3535
• Device Lot Number: 200428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 01/19/2021
• 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: Required Intervention