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

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2023

Event Type  Injury  

Event Description

The user facility reported that the catheter broke inside the patient and distal end had to be retrieved with a snare.It appeared the catheter was sheared due to the biopsy device.The patient was stable and there was no issue post operation.The procedure being performed was trans jugular liver biopsy.No estimated blood loss.There was no patient injury.

• 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: 18463824
• MDR Text Key: 332299277
• Report Number: 2243441-2023-00052
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• 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 Model Number: N/A
• Device Catalogue Number: CG415
• Device Lot Number: 230206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2024
• Distributor Facility Aware Date: 08/24/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SNARE.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White