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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2023
Type of Reportable Event	Death
Event or Problem Description
The user facility reported that they had an incident with the involved 018-gold tip glide product.The gold tip broke off inside the patient and were able to snare it.The wire was snared and there was no injury to the patient.The patient was in stable condition.The outcome of the procedure was unsuccessful.The event occurred intra-operative.The patient was not injured, and surgical intervention was not required.Additional information was received (b)(6) 2023: the glide wire gold was being used to cross a tight iliac lesion.The wire was advanced through a 65cm kumpe catheter to the lesion and advanced slowly.The wire prolapsed a few times and then engaged the calcified lesion.When the wire would not advance anymore, the physician pulled the wire back to try to find a new channel, when he noticed the gold marker was not on the end of the wire.Upon further inspection under flouro, they noticed the broken tip of the wire was lodged in the iliac calcium, but enough was hanging out that they felt they could snare the broken piece.They were successful in capturing the broken piece of wire with the snare and it was removed from the body and confirmed by fluoroscopy.The broken tip/piece is included with the sample.The sample was used in the body; thus, it is contaminated with blood.No infections agents present.The wire was not used in the presence of chemo.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section b.In the initial report submitted the selection for death in section b2 was in inadvertently checked.

• 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: 16668499
• Report Number: 2243441-2023-00016
• Device Sequence Number: 17623489
• Product Code: DQX
• UDI-Device Identifier: 04987350774194
• UDI-Public: 04987350774194
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023
• Report Date (Section F): 04/03/2023

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GM1811
• Device Lot Number: 211122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/06/2023
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KUMPE CATHETER
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 04/03/2023