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

Model Number 207F1

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

Patient Problem Heart Block (4444)

Event Date 01/01/2021

Event Type  Injury  

Event Description

A journal article was reviewed that contained information regarding empiric slow-pathway ablation in pediatric patients.The article reports patients who developed transient atrioventricular (av) block that improved before the procedure ended; some av block developed due to mechanical trauma during the catheter replacement and others developed during the ablation.Av block occurred during five of the cryoablations and one occurred during radiofrequency ablation.There was one patient who, after a third ablation, was implanted with an implantable pulse generator (ipg) due to complete av block.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.

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.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 female/13 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.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 was made.If additional information is obtained regarding this event, it will be added, and a supplemental report will be submitted accordingly.Referenced article:empiric slow-pathway ablation results for presumed atrioventricular nodal reentrant tachycardia in pediatric patients.Pacing and clinical electrophysiology.2021.44:1200¿1206.Doi: 10.1111/pace.14291.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREEZOR 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: 13020355
• MDR Text Key: 283611677
• Report Number: 3002648230-2021-00576
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 207F1
• Device Catalogue Number: 207F1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• 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): Other
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 45 KG