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	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cryo ablation procedure, the balloon would not inflate.The balloon catheter was replaced and the console rebooted, without resolve.Additionally, low pressure regulator (lpr) values were not as expected.Another inflation was then attempted, and the balloon was able to inflate, but then suddenly deflate.It was also reported that the system flush could not be initiated, and the account was running shorter inflations.Moreover, the coaxial umbilical cable was noted to have moisture within, and the coaxial cable was replaced without resolve.Additionally, the coaxial icon appeared on the screen and flow value was not as expected.The coaxial cap was replaced, and the console was again rebooted without resolve.The cv4 was checked, with no resolve.The case was aborted, and the patient was under general anesthesia.A field service visit on the console was recommended.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files showed multiple applications were performed with an unrelated catheter on the date of the event with no issue.The product issue reported, early deflation 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.The reported issue was not confirmed through data analysis.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event summary: the patient data files showed at least twenty applications were performed with catheter 2af283 / 85043-06 on the date of the event with no system issue.The visual inspection showed that the check valve lift was intact with no apparent issues.Assembled to rohs console and following a warm up time of 30 minutes, the console along with balloon test catheter failed the performance test due to the coaxial animation appearing when the coaxial umbilical and electrical umbilical cables were connected to the catheter.For the console 106a3/n6374, the product has not been returned for investigation and is still in use.The field service engineer could not duplicate inflation and deflation issues.Confirmed the low-pressure regulator setting was at 118 when first checked and was adjusted to 129psi.Verified flow under vacuum sitting at 527.Found to be caused by cv4 latching open causing added flow.Part replaced.Unit was tested, and concluded unit was ok to use.In conclusion, the reported high baseline flow/inflation issue was confirmed through testing but not confirmed through the data analysis.The check valve lift failed performance test due to the coaxial animation being triggered.The console is still in the field after the replacement of the check valve lift.The product issue reported (high baseline flow/inflation) 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: 6897672
• Report Number: 3002648230-2017-00539
• Device Sequence Number: 13657921
• Product Code: LPB
• UDI-Device Identifier: 00613994775955
• UDI-Public: 00613994775955
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/18/2017; 11/28/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 11/14/2017; 12/20/2017
• 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