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

Model Number 4FC12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 990063-020 mapping catheter, 2af284 balloon catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the patient developed a cardiac tamponade with pericardial effusion.The case was aborted while the patient was under general anesthesia.The effusion was drained and the patient hospitalized for an extra day for monitoring.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least five applications were performed with the 2af284 balloon catheter with lot number 00768 without any issue on the date of the event.In conclusion, the reported pericardial effusion, tamponade, and aborting of the case with the patient under general anesthesia occurred during the procedure.There is no indication of a relation of the adverse event to the performance and malfunction of the product.The physical product was not returned for analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 10738545
• MDR Text Key: 213171029
• Report Number: 3002648230-2020-00562
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000217136
• UDI-Public: 00763000217136
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010305398
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention