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

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/03/2023

Event Type  Injury  

Event Description

The user facility reported that the glidewires used in the procedure were damaged.The coating of the wires were pulled back and the inner wire was exposed.A prime removal was done from the patient.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18464213
• MDR Text Key: 332381919
• Report Number: 2243441-2023-00057
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 220531
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2024
• Distributor Facility Aware Date: 08/04/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention