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

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2024

Event Type  Injury  

Event Description

The user facility reported that during a peripheral procedure, the glidecath was over the iliac bifurcation over an amplatz wire.The doctor was removing the glidecath to exchange for a navicross and felt some resistance but could not determine what was causing it.He pulled on the glidecath and it broke apart leaving approximately 15cm in the patient.He was able to pull the wire with the remaining catheter into the destination sheath to remove safely.The case was finished successfully and no harm to the patient.The procedure was a left leg angio.There was no blood loss.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18947311
• MDR Text Key: 338184815
• Report Number: 2243441-2024-00004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 230522
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2024
• Distributor Facility Aware Date: 02/20/2024
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White