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

Model Number 106A3

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2014

Event Type  Injury  

Event Description

Information received by medtronic indicated that the user was unable to begin a cryoablation procedure due to issues powering on the cryoconsole.Technical support was called during the case and were unable to resolve the issue with this cryoconsole.The case was aborted; the patient was under general anesthesia for the procedure and did not receive any therapeutic treatment.There were no patient complications.

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 was reproducible during site visit.The console's original power supply and 6a fuse were replaced and the issue was resolved; all other fuses were inspected and found to be intact.The console's mother board and watchdog board were also replaced.All catheter and console safety tests passed without anomaly and the console was ready for use.Suspected defective parts of the cryoconsole were returned for evaluation.The reported issue has been confirmed through testing and data analysis.The returned power supply failed the inspection due to power off.The returned mother board and watchdog board passed the performance test as per specification.This failure type shall be monitored and trended.

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: 4089775
• MDR Text Key: 4739830
• Report Number: 3002648230-2014-00154
• 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
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• 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: 09/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• 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
• Patient Age: 00051 YR
• Patient Weight: 75