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	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The event description states: "patient is an adult male with medical h/o significant for morbid obesity, ef 20-25% and hypothyroidism who presented to the ed with sudden onset chest pain.Due to post vf arrest with known non-ischemic cardiomyopathy, an icd was indicated.Patient underwent procedure for dual chamber icd implantation.Difficulties were encountered advancing the wire; thus, a slippery guidewire was used, and the distal end was sheared off likely extra vascularly, attempts to remove it was not successful.Fluoroscopy completed after procedure and was not able to pick up wire.Venogram also completed and confirmed wire was not in vein.Outcome: likely will have minimal to no impact to patient.Patient will follow up with physician as outpatient.The original intended procedure was an icd implantation.Preexisting characteristics that may have contributed to the event: morbidly obese." additional information was received on 31 jan 2023: the patient was in stable condition.The procedure was completed successfully.Surgical intervention was not performed.No equipment or other devices were used with the product involved.Additional information was received on 02 feb 2023: there were two (2) ml's of blood loss.The wire was not removed.

• 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
• MDR Report Key: 16410533
• Report Number: 2243441-2023-00007
• Device Sequence Number: 14793074
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: 04987350773630
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2023
• Report Date (Section F): 02/21/2023

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: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3508
• Device Lot Number: 210827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2023
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 146 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 02/21/2023