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	01/26/2018
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, the low pressure regulator (lpr) was not as expected.Additionally, a system notice was received indicating that the system detected an electrical component failure.The electrical path was disconnected and reconnected with resolve.Additionally, a system notice was received indicating that the balloon was not sufficiently inflated.The coaxial umbilical cable and balloon catheter were replaced without resolve.It was also reported that pressure was not as expected.A field service visit was recommended.The case was aborted, and the patient was under general anesthesia.No patient complications have been reported as a result of this event.On 2018-02-12: information indicated that a field service visit took place and the power supply voltage was out of tolerance.The console was serviced as appropriate.The product issue reported 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.
Additional Manufacturer Narrative
Product event summary: data files and field service engineering report (fser) were reviewed and analyzed.Data files confirmed a system notice indicating that the system detected an electrical component failure (#50002) during application with the balloon catheter.Bin files showed at least 10 applications were performed with this catheter on the date of the event and all the applications had unsuccessful inflation.The fser noted that the check valves were replaced, and the power supply voltage was out of tolerance.The console was tested and deemed appropriate for clinical use after repairs.Furthermore, the product issue reported #50002 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: 7284351
• Report Number: 3002648230-2018-00102
• Device Sequence Number: 10798986
• Product Code: LPB
• UDI-Device Identifier: 00643169203150
• UDI-Public: 00643169203150
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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: 01/26/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/27/2018
• 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