MAUDE Adverse Event Report: MICRO CATHETER; CATHETER, CONTINUOUS FLUSH

Device Problems Material Puncture/Hole (1504); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

During a cerebral angiogram beca the micro catheter that was being used to deliver onyx had a hole / malfunctioned.As a result the onyx was deployed in an area that was not intended.The catheter was removed upon discovery.No injury to patient noted.Fda safety report id# (b)(4).

• Brand Name: MICRO CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• MDR Report Key: 13118800
• MDR Text Key: 283139494
• Report Number: MW5106390
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 168 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White