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 Cardiopulmonary Arrest (1765); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 12/14/2017

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, the patient had a pericardial effusion, which was confirmed via intracardiac echocardiography (ice).The case was aborted, and the patient was under general anesthesia.Subsequently, the patient required cardiopulmonary resuscitation (cpr), and open chest thoracotomy.The patient was then transported to the operating room (or) for a subsequent procedure or surgery.The patient's hospitalization was extended.The patient is recovering, and the extent of permanent injuries were unable to be determined.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files did not show any system notice for the date of the event.The sheath was not returned and there was no indication of a product malfunction.Some known clinical issues (cardiac perforation, pericardial effusion, tamponade and pulmonary vein tear) were encountered during the procedure.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received indicated that during the open chest thoracotomy, a pulmonary vein (pv) tear was found and repaired.Additionally, the patient has since been discharged home.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7139815
• MDR Text Key: 95582869
• Report Number: 3002648230-2017-00715
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 58287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR