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

Model Number 106A3

Device Problems Failure to Power Up (1476); Failure to Read Input Signal (1581)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2014

Event Type  Injury  

Event Description

Information received by medtronic indicated that the user was unable to begin a cryoablation procedure due to an issue with the cryoconsole.It was reported that the screen of the cryoconsole showed the message "no input detected" and that the cryoconsole would not power on.The case was aborted; the patient was intubated and under general anesthesia for the procedure and did not receive any therapeutic treatment.No patient complication reported.

Manufacturer Narrative

Investigation is in progress.Results of investigation will be submitted in a supplemental report.

Manufacturer Narrative

Technical support was notified of this occurrence.Upon review of complaint information, a service order was initiated to review the console performance on site.The reported issue has been confirmed by field service engineering.The issue was resolved by replacing the console patient board.This report will be recorded and trended.

Manufacturer Narrative

Technical support was notified of this occurrence.Upon review of complaint information, a service order was initiated to review the console performance on site.The reported issue has been confirmed by field service engineering.The issue was resolved by replacing the console patient board.The defective patient board was returned for analysis.The patient board was inspected and assembled to a cryoconsole.The console was rebooted and failed the power up test.The reported issue ¿no input detected¿ has been confirmed through testing.

Manufacturer Narrative

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

• Brand Name: CRYOCONSOLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 3902041
• MDR Text Key: 4652761
• Report Number: 3002648230-2014-00104
• Device Sequence Number: 1
• Product Code: LPB
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other