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

Model Number 217F5

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

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

Event Date 01/20/2024

Event Type  Injury  

Manufacturer Narrative

Product event summary: the patient data files and 217f5 electrophysiology (ep) catheter with lot number 18813 were returned and analyzed.The clinical data was analyzed.No patient file or failure file was received.During external visual inspection of the electrocardiogram (ecg) ring, shaft, and handle segments, no anomalies were identified.The catheter smart chip data was reviewed.The data indicated the catheter was never used (no applications were performed).Without reprogramming the catheter, it was connected to the test console for system performance testing.During system performance testing with the console, the catheter passed the performance testing as per specifications.All the phases were completed without triggering any system notices.No performance issues were identified.The decision to abort the procedure without use of alternate therapy was based upon the medical judgement of the physician.In conclusion, the electrophysiology (ep) catheter did not fail the returned product inspection as the reported temperature issue was not confirmed through testing and aborted under general anesthesia cannot be assessed through data analysis.Continuation of d10: product id: 217f5 product type: electrophysiology (ep) catheter 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.

Event Description

It was reported that during a cryo ablation procedure, the electrophysiology (ep) catheter could not get warm and initiate the system check.The electrophysiology (ep) catheter was replaced without resolution.The electrophysiology (ep) catheter was replaced again with another manufacturer's product. the case was switched to radiofrequency (rf) but was later aborted while the patient was under general anesthesia. no further 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: 18875731
• MDR Text Key: 337336121
• Report Number: 3002648230-2024-00079
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00763000542115
• UDI-Public: 00763000542115
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 217F5
• Device Catalogue Number: 217F5
• Device Lot Number: 18813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other