MAUDE Adverse Event Report: TERUMO CORPORATION GLIDECATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number CG511

Device Problem Material Rupture (1546)

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

Event Date 01/07/2022

Event Type  malfunction  

Event Description

Staff reported the terumo catheter "ruptured" during injection in a diagnostic cerebral angiogram procedure.No injury was identified related to the event.

• Brand Name: GLIDECATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 13470588
• MDR Text Key: 285153452
• Report Number: 13470588
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CG511
• Device Catalogue Number: YA25110A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1