MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR XTRA CARDIAC CRYOABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 217F1

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the electrophysiology (ep) catheter with lot 17210 was returned and analyzed.During visual inspection of the ep catheter, a snapped shaft was observed, and a folded shaft was observed.During external visual inspection of the shaft segment, a snapped shaft was observed at 43 inches from the catheter tip at the shaft strain relief.During external visual inspection of the shaft segment, a folded shaft was observed at 2 inches from the catheter tip.The catheter smart chip data was reviewed.Data indicated that the ep catheter was used for 11 applications on the reported event date.The performance test with the console was not able to be performed as the ep catheter shaft was snapped at the shaft strain relief.In conclusion, the electrophysiology (ep) catheter failed the returned product inspection due to a snapped shaft and a folded shaft.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, multiple system notices were received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The coaxial umbilical cable was disconnected and reconnected which did not resolve the issue.The catheter was replace twice and the issue remained.The coaxial umbilical cable, auto connection box and electrical umbilical cable were replaced which did not resolve the issue.It was verified that the tank was opened and had sufficient gas for the case.The case was switched to radiofrequency.  the patient remained hemodynamically stable during the entire case. the case was completed with radiofrequency.The bin files were reviewed and there were no pressure overshoots.Test injections were performed after the case and it appeared that the console was controlling pressure and flow in the expected ranges. no patient complications have been reported as a result of this event.

• Brand Name: FREEZOR XTRA CARDIAC CRYOABLATION CATHETER
• 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
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16632467
• MDR Text Key: 312420094
• Report Number: 3002648230-2023-00130
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00763000542092
• UDI-Public: 00763000542092
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 217F1
• Device Catalogue Number: 217F1
• Device Lot Number: 17210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female