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

Model Number CG415

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

An endovascular intervention on the patient's aorta was being done.When the glidecath was pulled out, approximately 12cm sheared off and was left inside the patient's aorta.The surgical team spent approximately 30 more minutes but were successful in removing the broken pieces.There was no significant complications but could have been a catastrophe.Manufacturer response for catheter, intravascular, diagnostic, glidecath (per site reporter).Terumo will be working with the hospital to issue credit for the broken catheter.Currently gathering information about the event to provide to terumo.

• Brand Name: GLIDECATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 13847918
• MDR Text Key: 287618871
• Report Number: 13847918
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2022

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: CG415
• Device Catalogue Number: RF*ZV9410GA
• 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: 03/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Female
• Patient Weight: 37 KG
• Patient Race: White