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

Model Number 106A3

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/30/2018

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, after the first full injection, a second inflation was attempted.The balloon did not inflate, and a system notice was received indicating that the balloon was not sufficiently inflated.The balloon catheter was replaced without resolution.The low-pressure regulator (lpr) was checked and it was out of tolerance.The system was vented without resolution.The case was aborted, and the patient was under general anesthesia.No 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

Additional information reported that a field service visit took place on a later date and the console was serviced as appropriate.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that at least 7 applications were performed with balloon catheter, 2af284 with lot number 34418 on the date of the event.The console was serviced on the field.The console was vented, and the digital gauge was zeroed to get an accurate pressure value.The low-pressure regulator (lpr) was adjusted by small intervals to correct the pressure in the system.The console was vented, and the tank was opened to make sure pressure was consisted.The console failed the inspection due to an unadjusted lpr.The product issue reported (inflation issues) is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.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; 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7898960
• MDR Text Key: 121047333
• Report Number: 3002648230-2018-00677
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• 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,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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): Other
• Patient Age: 71 YR
• Patient Weight: 138