MAUDE Adverse Event Report: ARROW BALLOON CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNKNOWN

Device Problem Unintended Movement (3026)

Patient Problem Vascular Dissection (3160)

Event Date 12/13/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, this balloon catheter was involved on a dissection of the coronary sinus which was observed during venography.The dissection was due to the use of the balloon catheter.The rest of the procedure went well.There was no other complication and the patient is fine.The physician was dr.(b)(6) at (b)(6) in (b)(6).No additional information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BALLOON CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ARROW
• MDR Report Key: 17519855
• MDR Text Key: 321058997
• Report Number: MW5126803
• 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: 01/15/2014

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
• Patient Sequence Number: 1