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 03/27/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least one application was performed with balloon catheter, 2af284 with lot number 69607, without any issue on the date of the event.System notice 50024 ¿vent system failure¿ was confirmed on the date of the event.Additionally, system notice 11200 ¿there is a problem with the system¿ was also confirmed.The product issues reported are 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.

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the balloon was deflated.Then, a system notice was received indicating that there was a problem with the refrigerant port.The console was rebooted.It was then indicated that frost was observed on the port.A system notice was then received indicating that there is a problem with the system.Everything was disconnected from the console without resolve.Reconnecting the hospital adapter resolved the second system notice.Additionally, a hissing was heard from the console.The console was rebooted again and the catheter retracted back in the shaft after some difficulty.A field service visit took place on a later date.The coaxial cap was found to be damaged and the console was serviced as appropriate.The case was aborted as there was a leak in the console.No patient complications have been reported as a result of this event.Additional information reported that the patient was under general anesthesia.

Manufacturer Narrative

Product event summary: some parts of the console, 106a3 with serial number (b)(4), were returned and analyzed.Visual inspection of the injection panel showed that it was intact with no apparent issues.However, the injection panel failed the performance test due to an unadjusted low-pressure regulator.Additionally, visual inspection of the check valve showed that it was intact with no apparent issues.Inflation tests were performed, and it was sustained without triggering the high baseline flow animation.Finally, the coaxial cap was returned, and visual inspection indicated the arm was broken.These issues are 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 8617246
• MDR Text Key: 145290190
• Report Number: 3002648230-2019-00377
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169203150
• UDI-Public: 00643169203150
• Combination Product (y/n): N
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other