MAUDE Adverse Event Report: UNKNOWN CATHETER, PERCUTANEOUS

Model Number SSPC1

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this catheter had difficulty to split.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERCUTANEOUS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17527834
• MDR Text Key: 321374372
• Report Number: MW5134765
• Device Sequence Number: 1
• Product Code: DQY
• 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: 10/10/2019

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: SSPC1
• Patient Sequence Number: 1