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

Model Number	UWS5038
Medical Device Problem Codes	Material Frayed (1262); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Udi: since the lot number was unknown, only the only the di no.Is entered di no.(b)(4).Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date: unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Since the lot number was unknown, the manufacturing record and the shipping inspection record of the involved product code/lot number could not be reviewed.A search of the complaint file found no other similar report with the involved product code from other facilities.Since the lot number was unknown, the manufacturing record and the shipping inspection record could not be investigated.From the reported issue that "the wire was bent and frayed", it was inferred that the outer layer of guidewire was peeled off.However, since the actual sample was not returned and the condition of it could not be confirmed, it was not possible to clarify the cause of occurrence.Ashitaka factory assures the quality of this product by performing following controls.(i) 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.(ii) 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 warning.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
Terumo medical received an fda medwatch report number mw5112757.The event description stated that the patient was in the operating room for a cystoscopy, left retrograde pyelogram, bilateral ureteronephroscopy, ureter wire removal and left holmium laser lithotripsy and left double j stent placement.When the 0.038 angled stiff glide wire was removed from the patient, it was noted by surgeon that the wire was bent and frayed.Olympus.

• 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 ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15866761
• Report Number: 9681834-2022-00237
• Device Sequence Number: 2532217
• Product Code: KOD
• UDI-Device Identifier: 04987350755117
• UDI-Public: 04987350755117
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: D017023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2022

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 Model Number: UWS5038
• Device Catalogue Number: 1RF*PA38153U
• 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: 10/28/2022
• Initial Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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