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

Model Number 227F3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/(b)(6) years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: strategies for catheter ablation of left ventricular papillary muscle arrhythmias an institutional experience.2020.6 (11); 1381-92.Doi.Org/10.1016/j.Jacep.2020.06.026.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding catheter ablation of left ventricular papillary muscle arrhythmias.The article reports patients that underwent ablation and experienced aortic dissection which required surgical repair and pericardial effusions which required pericardiocentesis.The status/ disposition of the catheters is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11637259
• MDR Text Key: 257423072
• Report Number: 3002648230-2021-00168
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 227F3
• Device Catalogue Number: 227F3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR