MAUDE Adverse Event Report: MEDTRONIC, INC ACHIEVE CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

During a cryo ablation procedure, a clot formed in the left atrium.Patient was brought into the room for the procedure.Patient was positioned on table.Ensite x patches applied per ifu.Anesthesia completed prep and intubation.Patient was prepped and draped in usual manner.Local anesthesia to rt and lt groin.Multiple access sitex obtained and diagnostic catheters (abt - supreme quad / inquiry quad / viewflex xtra) positioned in the his, rv and ra sites.Baseline act obtained and result was 170 secs.Mdt cryo balloon / mdt achieve catheter prepped and inserted into la.Ensite x system final setup completed per ifu.La geometry and pre-ablation voltage mapping started.Act drawn.Clot visualized on ice and consult called which confirmed clot formation on ice.Act result was 310 sec.To remove the clot, negative pressure was applied to the mdt flexcath sheath as the mdt cryo balloon and mdt achieve catheter were slowly withdrawn into the sheath and removed from the la.Access sites attended to by lab staff.Protamine was not administered.Act drawn.Act result was 279 sec.No additional complications were demonstrated.The patient was extubated and sent to post procedure recovery.Reference reports mw5152845, mw5152846, mw5152847.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ACHIEVE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC, INC
• MDR Report Key: 18911791
• MDR Text Key: 337908898
• Report Number: MW5152848
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2024
• Patient Sequence Number: 1