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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the outside coating of the wire stripped while advancing through a micro catheter in the body during a lower extremity angiogram.Additional information was received on 17-december-2021: the wire stayed inside the microcatheter.The patient was stable, and the procedure was completed successfully.The procedure was not completed by using the wire, everything was retracted and exchanged.
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.Review of the manufacturing record and the product-release judgement record of the involved product/lot# combination confirmed that there were not any problems in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.According to the investigation results, no abnormality was found in the manufacturing records.In this case, the actual sample was not returned and the details of the occurrence were unknown, therefore the cause of occurrence could not be clarified.Ifu states: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire 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." please see mdr (b)(4) for the importer report.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).
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Review of the manufacturing record and the product-release judgement record of the involved product/lot# combination confirmed that there were not any problems in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.According to the investigation results, no abnormality was found in the manufacturing records.In this case, the actual sample was not returned and the details of the occurrence were unknown, therefore the cause of occurrence could not be clarified.Ifu states: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire 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." please see mdr (b)(4) for the importer report.(b)(4).
Event or Problem Description
The user facility reported that the outside coating of the wire stripped while advancing through a micro catheter in the body during a lower extremity angiogram.Additional information was received on 17-december-2021: the wire stayed inside the microcatheter.The patient was stable, and the procedure was completed successfully.The procedure was not completed by using the wire, everything was retracted and exchanged.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13180223
• Report Number: 9681834-2021-00252
• Device Sequence Number: 5346519
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2022

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: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 210519
• 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: 12/10/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRONETIC QUICKCROSS 135CM MICROCATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown