MAUDE Adverse Event Report: MEDTRONIC INC, -SWINNEA MICRO THERAPEUTICS MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  Injury  

Event Description

Catheter malfunction - small hole noted in the catheter which allowed the escape of onyx product into an unwanted vessel.The onyx was retrieved by an ir md.

• Brand Name: MICRO THERAPEUTICS MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC INC, -SWINNEA
• MDR Report Key: 16597977
• MDR Text Key: 311960739
• Report Number: MW5115926
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2023

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: 105-5056
• Device Lot Number: B481738
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ONYX
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female