MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 106A3

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

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

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

Product event summary: data files were returned and analyzed.Patient file number one showed eleven applications were performed with balloon catheter afapro28 with lot number 7580 on the reported date of the event and confirmed system notice 50014 (indicating that the balloon inflation pressure was not reached in time) applications one, two, three, four, five, six, seven, eight, nine, ten, and eleven.Patient file number two showed 22 applications were performed with balloon catheter afapro28 with lot number 7698 on the reported date of the event and confirmed system notice 50014 (indicating that the balloon inflation pressure was not reached in time) in applications one, two, three, four, five, six.Patient file number three showed one application was performed with balloon catheter afapro28 with lot number 7698 on the reported date of the event and confirmed system notice 50014 (indicating that the balloon inflation pressure was not reached in time) in application one.In conclusion, the reported system notice, 50014 was confirmed through data analysis.In conclusion, the reported issue (aborted under general anesthesia) cannot be assessed through data analysis.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.

Event Description

It was reported that during a cryo ablation procedure, the low pressure regulator (lpr) pressure was high, so the system was vented.The test injections were completed successfully.A system notice was received indicating that the balloon inflation pressure was not reached in time.The balloon catheter, coaxial umbilical cable and electrical umbilical cable were replaced which did not resolve the issue.The auto connection box was bypassed and the issue remained.The system was vented again and the issue remained.The check valve 7 (cv7)  was tapped which did not resolve the issue.No veins were ablated using cryoablation.The physician proceeded with the cavotricuspid isthmus (cti) line ablation using a radiofrequency (rf) catheter. the cryo ablation procedure for pulmonary vein isolation (pvi) was aborted and the patient was under general anesthesia. the data files were reviewed and confirmed the system notice.No patient complications have been reported as a result of this event.

• Brand Name: CRYOCONSOLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17826930
• MDR Text Key: 324389041
• Report Number: 2182208-2023-02775
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: 00763000011147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male