MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

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

Patient Problems Hematoma (1884); Transient Ischemic Attack (2109); Cardiac Tamponade (2226)

Event Date 12/10/2022

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.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 characteristics is male.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 will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: the importance of anaesthesia in atrial fibrillation ablation: comparing conscious sedation with general anaesthesia.Indian pacing and electrophysiology journal 23 (2023) 47-52.Doi: 10.1016/j.Ipej.2022.12.001 if information is provided in the future, a supplemental report will be issued.

Event Description

Literature was reviewed regarding cryoballoon ablation.The authors described patients who experienced procedural complications, which included pericardial tamponades, both were treated with a subcostal drain, and one transient ischemic attack (tia).There were minor complications which included groin hematomas, neither required an intervention, transient hemoptysis, and transient phrenic palsies.The status of the catheters and sheaths is unknown.No additional adverse patient effects were reported.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• 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: 16678657
• MDR Text Key: 312671655
• Report Number: 3002648230-2023-00157
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/04/2023
• 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 Sex: Male