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

Catalog Number ZV9410GA

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2023

Event Type  malfunction  

Event Description

During aortogram with left leg angiogram a 4fr angled glide catheter broke, leaving a large remnant in patient.The catheter was appropriately flushed preop during procedure set up and no damage was noted.When md advanced the glidewire advantage through the catheter, he felt a snap and tried to pull catheter out, that's when he noticed the catheter had broken off.An aortogram was performed and a remnant piece of catheter was able to be snared out.The catheter and remaining remnant were placed in biohazard bag and given to asst.Manager as this appears to be a manufacturer issue.

• Brand Name: GLIDECATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 18029479
• MDR Text Key: 326851113
• Report Number: 18029479
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZV9410GA
• Device Lot Number: 230322
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1