MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved 260 stiff glide device frayed during a peripheral procedure.The proximal end of the wire frayed, which was outside the patient and not in the sheath or catheter.Patient was in stable condition.The procedure outcome was successful.The event occurred intra-operative.The patient was not injured, medical or surgical intervention was not required.There were no other devices or equipment used with the reported product.Additional information was received on 19 jub 2023: it started to peel during the case.It was not specified if it was caused by a torque or any other object, but the peeling was caused during manipulation.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: nurse manager.The actual device was not available for returned; therefore, an evaluation of the actual device will not be conducted.Based on the additional information that the actual sample started to peel during the case, the problem pointed out was judged to be the peeling of urethane.Review of the manufacturing record and the shipping inspection record confirmed that there was not any anomaly in them.A search of the complaint file found no other similar complaint related to the involved product code/lot # from other facilities.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 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 guidewires are 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 anomaly in the appearance such as exposure of core or scratch on the surface.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 4103927218
• MDR Report Key: 17244603
• Report Number: 9681834-2023-00127
• Device Sequence Number: 20042352
• Product Code: DQX
• UDI-Device Identifier: 04987350773210
• UDI-Public: 04987350773210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/02/2023

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: GR3509
• Device Lot Number: 220329
• 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: 06/02/2023
• Initial Report FDA Received Date: 07/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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