MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the procedure performed was a paravalvular aortic leak.The physician attempted to canulate the leak with the glide catheter involved.It was noted during the procedure the glide catheter felt snug/tight inside the leak.The physician attempted to remove the glide catheter and had to pull with more force than usual.It was noted the tip had broken off and was left in the leak.A snare was inserted and removed the broken tip safely.No harm to the patient and the procedure was able to be completed.The patient was in stable condition.The paravalvular plug procedure was completed successfully.There was no patient injury or surgical intervention required.Additional information was received on 21 mar 2023: an angiography was used to determine that the entire broken tip was safely removed.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18220961
• Report Number: 2243441-2023-00045
• Device Sequence Number: 5671603
• Product Code: DQO
• UDI-Device Identifier: 04987350772237
• UDI-Public: 04987350772237
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2023
• Report Date (Section F): 11/28/2023

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: CG417
• Device Lot Number: 220315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/20/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 11/28/2023