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); Loss of consciousness (2418); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the transseptal puncture was performed with a competitor device and exchanged for the sheath.Prior to the first inflation with the sheath and balloon catheter in the heart, it was noted that the left heart border did not appear to be moving on the x ray.Imaging was preformed again and the heart border appeared to be moving.A fluorograph and echocardiogram were performed after the patient was given cardiopulmonary resuscitation (cpr) and a pericardial effusion was observed.The physician requested blood and the anesthesiologist.A sternotomy was performed and the patient was found to have a small hole on the ridge between the left atrial appendage and the left superior pulmonary vein.The procedure was aborted.Surgical intervention was performed successfully and the patient was stabilized.It was later noted by the physician that the trans-septal puncture was "clean" and there was a possibility that the tear was caused by the competitor guidewire but the physician was not sure.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the patient was found to be unresponsive to name, and remained unresponsive.Therefore, an echo, drain, and subsequent surgical intervention were performed.No further patient complications have been reported as a result of this event.

• 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: 7067780
• MDR Text Key: 93229568
• Report Number: 3002648230-2017-00648
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 69979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• Date Device Manufactured: 09/08/2017
• 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
• Treatment: 990063-20 MAPPING CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention