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 Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least eight applications were performed with balloon catheter 2af284 with lot 11346 and system notice 50008 ¿the system has detected a software error and stopped the injection¿ was triggered in the first application.In conclusion, the reported cardiac tamponade could not be confirmed through testing.There is no indication of relation of adverse event to the performance of the cryo device.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 patients vitals signs decreased and cardiopulmonary resuscitation was initiated.A cardiac tamponade was noted and pericardiocentesis was performed.The patient required surgical intervention to repair a tear to the pulmonary vein resulting in an extended hospital stay and patient remains in the hospital on ventilation support with steady improvements.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: 8956234
• MDR Text Key: 156408916
• Report Number: 3002648230-2019-00635
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000043773
• UDI-Public: 00763000043773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 63607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR