MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 106A3

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

Patient Problem Exit Block (2628)

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

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 experienced an atrioventricular (av) block.The electrophysiology (ep) catheter continued to apply therapy after attempting to stop the ablation with the foot pedal.The cables were disconnected from the console in an attempt to stop the ablation.The case was aborted while the patient was under general anesthesia.After monitoring the intermittent av block, the patient was implanted with a pacemaker.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Incoming information indicated the 'blue button used to inflate the balloon' was not working; the console began the self-check process automatically and 'the balloon inflated.' additionally, the patient was admitted for a day and a bi-ventricular pacemaker was placed.

• Brand Name: CRYOCONSOLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 8729161
• MDR Text Key: 149055393
• Report Number: 3002648230-2019-00455
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169672475
• UDI-Public: 00643169672475
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020045
• 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,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Device Lot Number: 19427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention