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

Model Number	106A3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information reported that a field service visit took place on a later date and the console was serviced as appropriate.
Additional 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
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 7898960
• Report Number: 3002648230-2018-00677
• Device Sequence Number: 19259099
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 10/09/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/04/2018; 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 138