MAUDE Adverse Event Report: MEDTRONIC FLEXCATH ADVANCE; CATHETER, STEERABLE

Device Problem Unintended Movement (3026)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/02/2018

Event Type  Injury  

Event Description

This letter is to informyou of this adverse event ifrhe suspectecfaevice of medtronic sheath -(4fc'12) flexcathadvance 12fr (b)(4) is not manufactured or imported by biosense webster, inc.Event description: tamponade during pvl ablation with cryobalon requiring pericardiocentesis.Additional information provided was that the physician's opinion regarding the cause of the adverse event is that it was procedure-related.Did not retire correctly the sheath; therefore, maybe it was done too fast which might have caused the injury.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FLEXCATH ADVANCE
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17530462
• MDR Text Key: 321080487
• Report Number: MW5137381
• Device Sequence Number: 1
• Product Code: DRA
• 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: 10/29/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1