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 Arrest (1762); Perforation (2001); Cardiac Tamponade (2226)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 990063-020 mapping catheter. Product event summary: the data files were returned for analysis. The files showed that at least 17 applications were performed with a returned balloon catheter without any issue on the date of the event. In conclusion, the clinical issues, perforation, tamponade and cardiac arrest, occurred during the procedure. There is no indication of relation of the adverse event to the performance or a malfunction of the product. If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, the patient experienced cardiac tamponade after the heart was perforated. A pericardial puncture was performed to drain the fluid surrounding the heart. The patient then went into cardiac arrest. Cardiopulmonary resuscitation (cpr) was performed and the patient stabilized. The case was aborted. No further patient complications have been reported as a result of this event.

• 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
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13044140
• MDR Text Key: 282504017
• Report Number: 3002648230-2021-00580
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010860898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/20/2021 Patient Sequence Number: 1

Treatment

AFAPRO28 BALLOON CATHETER