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	11/03/2017
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 cryoablation procedure, a system notice was received indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable.The coaxial umbilical cable and electrical umbilical cable were replaced without resolve.It was then indicated that the high baseline flow icon displayed on the console.The coaxial umbilical cable was reconnected, the coaxial cap was reconnected, the vacuum was disabled, all without resolve.The case was aborted and the patient was under general anesthesia.A field service visit took place on a later date and the console was serviced as appropriate.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Event summary: the patient data files showed at least one injection was performed with catheter 2af284 / 96333-09 on the date of the event.A system notice (#50001) was received indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable was triggered.For the console 106a3 / n6858, the product has not been returned for investigation and is still in use.Technical support was notified of this occurrence.The reported issue does not indicate console¿s manufacturing related defect.Upon visual inspection of the adjustable check valve 12002-232-001/lz4290001 (cv6), results showed that the check valve was intact with no apparent issues.Assembled to gen v universal console, the console along with balloon test catheter completed the performance test.However, the inflation was only sustained for less than 200 seconds.Using inflation tool (60002-365) the pt5 (pressure transducer) reading could not maintain for over three minutes on passive scavenging, and a high baseline flow warning was triggered.The cv-6 was non-functional and it was cv-6 replaced.The problem was resolved.In conclusion, the reported system notice (#50001) was received indicating that the vacuum was disabled due to a problem with the co axial umbilical cable was confirmed through the data analysis.The reported clinical issue was not confirmed through the data analysis or through the testing.Adjustable check valve 12002-232-001/ lz4290001 (cv6) failed the return product inspection due to the triggered high baseline flow warning.The console is still in use after the replacement of cv6.The product issue reported (system notice #50001) 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: 7054397
• Report Number: 3002648230-2017-00645
• Device Sequence Number: 903325
• Product Code: LPB
• UDI-Device Identifier: 00643169279063
• UDI-Public: 00643169279063
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 01/04/2018

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?: Yes
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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