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

Model Number 106A3

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files for the 106a3 console with serial number (b)(4).Were returned and analyzed.No system notices were recorded in the data files for the date of the event, though a startup error was seen in the data files.In conclusion, 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, there was a pressure release "popping" sound.It was recommended to reconnect the balloon catheter but then nothing popped up on the screen.Entering the therapy screen, a system notice was received indicating that the electrical system was not initialized.Connections were removed temporarily while the console was reset.Multiple system notices were received indicating that there is a problem with the system with board level errors.Entering the system feature test the "daq" failed consistently.The case was aborted while the patient was under general anesthesia.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the watch dog board with serial number (b)(6) for the 106a3 console with serial number (b)(6) was returned and analyzed.Visual inspection showed that the board was intact with no apparent issues.When assembled to console and following a warmup time of 30 minutes, the console along with balloon test catheter failed the performance test.In conclusion, watch dog board failed the returned product inspection.However, if the malfunction were to re-occur, it is not likely to cause or contribute to a death or serious injury.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: 11966703
• MDR Text Key: 257424821
• Report Number: 3002648230-2021-00289
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: 00763000011147
• 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
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• 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: 06/11/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other