MAUDE Adverse Event Report: CODMAN CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNKNOWN CATHETER

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported the patient's catheter was cut in half (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CODMAN
• MDR Report Key: 17519033
• MDR Text Key: 321322608
• Report Number: MW5125981
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN CATHETER
• Patient Sequence Number: 1