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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, not provided, age & date of birth: requested, not provided, patient sex: requested, not provided, weight: requested, not provided , ethnicity: requested, not provided, race: requested, not provided , implanted date: device was not implanted, explanted date: device was not explanted, occupation: lead tech.Since the actual sample was not returned to ashitaka factory, investigation of it was unable to be performed.The provided photo was confirmed.It was found that the outer layer of guidewire was peeled off.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual product was not returned and investigation could not be performed, it was not possible to clarify the cause of occurrence.Ashitaka factory assures the quality of this product by performing following controls.The guidewire is passed through the dedicated tool on 100% basis to confirm that there is no peeling of the outer layer or adhesion of any foreign substances on the surface of guidewire.Before the packaging process, 100% visual inspection is performed to confirm that there is no exposure of the core wire or anomaly in its appearance.Instructions for use (ifu) of this product includes the following warnings."if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glide wire 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 manipulate or withdraw the glidewire through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The distributor reported that there was a possible out of box (oob) failure with the guidewire involved.It was reported that the coating came off the guidewire and was noted to be in the patient.There was no death or injury including infection.It is not likely that the malfunction of the reported event could cause or contribute to a death or injury.The event occurred intra-operative.The patient condition is unknown.The procedure outcome was unknown.Additional information was received on 23 aug 2022: the procedure performed was a cysto-uroscopy.There was a possible kidney stone with laser.

• Brand Name: RADIFOCUS GLIDEWIRE UROLOGIC WIRE
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15820117
• Report Number: 9681834-2022-00229
• Device Sequence Number: 14621364
• Product Code: KOD
• UDI-Device Identifier: 04987350755575
• UDI-Public: 04987350755575
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: UWS1035
• Device Lot Number: 211118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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
• Patient Sex: Unknown