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

Model Number N/A

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18220961
• MDR Text Key: 329161128
• Report Number: 2243441-2023-00045
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772237
• UDI-Public: 04987350772237
• 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: 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
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 11/28/2023
• Distributor Facility Aware Date: 03/20/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White