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

Model Number 217F5

Device Problem Material Integrity Problem (2978)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the 217f5 electrophysiology catheter with lot number 13921 was returned and analyzed.Visual inspection of the electrophysiology catheter was performed.No anomalies were identified during external visual inspection of the electrocardiogram (ecg) ring, shaft, and handle segments.The catheter smart chip data was reviewed.Data indicated that the catheter was used for 19 applications on the reported event date.During system performance testing with the test console, the console terminated the application and generated system notice 50005 "the safety system detected fluid in the catheter and stopped the injection." during pressure testing and inspection of the shaft segment, a leak was observed at the shaft attachment to the tip.In conclusion, the electrophysiology catheter failed the returned product due to a breach on the shaft.If information is provided in the future, a supplemental report will be issued.

Event Description

After a completed case, the electrophysiology (ep) catheter subsequently tested out of specification per the manufacturer's investigation.

• 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: 14316976
• MDR Text Key: 292513872
• Report Number: 3002648230-2022-00195
• Device Sequence Number: 1
• Product Code: LPB
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: 217F5
• Device Catalogue Number: 217F5
• Device Lot Number: 13921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Initial Date Manufacturer Received: 04/24/2022
• Initial Date FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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