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 Arrhythmia (1721); Cardiopulmonary Arrest (1765); Cardiac Tamponade (2226); Blood Loss (2597)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

Product event summary: data files were returned.However, it could not be analyzed due to being corrupted.The physical device was not returned for analysis or investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, difficulty was observed when engaging the pulmonary vein branches.The mapping catheter was replaced with a guidewire.Immediately after a freeze, a short asystole was observed and the patient was unresponsive.Additionally, severe arrhythmias were observed, and there was no measurable blood pressure.Resuscitation was then performed, and the case was aborted.Subsequently, a thoracotomy was performed which confirmed severe tamponade, and the bleeding could not be stopped completely.The patient was then transferred to a heart surgical center, under extracorporeal membrane oxygenation (ecmo).No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files for the date of the event were returned and analyzed.The files showed eight injections were performed with the balloon catheter without issue.Additionally, no system notices were received.A clinical issue was encountered during the procedure.There was no indication of a product malfunction and no physical product returned for analysis.If information is provided in the future, a supplemental report will be issued.

• 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: 7068597
• MDR Text Key: 93251791
• Report Number: 3002648230-2017-00650
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 12/12/2017

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 2ACH25 MAPPING CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 110