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 Cardiac Arrest (1762); Death (1802); Cardiac Tamponade (2226)

Event Date 07/18/2017

Event Type  Death  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure during the first freeze of the left inferior pulmonary vein (lipv) an acute loss of oxygen saturation occurred causing asystole.It was further reported that the patient experienced cardiac tamponade."mechanical and external reanimation" was performed and a thoracotomy was administered to evacuate fluid.The cause of the tamponade was unknown.The case was aborted and the patient was under general anesthesia.The patient was hospitalized in critical condition and transferred to another facility for additional treatment to eliminate pericardiac blood from the tamponade.It was noted that the entire region of the patient's left pulmonary vein (pv) was intact.No further patient complications have been reported as a result of this event.On 2017-08-08, 12:46:48: incoming information indicated that the mapping catheter and sheath were in the heart at the time of the tamponade.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the manufacturer's representative reported that the patient is deceased.

• 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: 6777128
• MDR Text Key: 82154361
• Report Number: 3002648230-2017-00427
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

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 Expiration Date: 06/05/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 48894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 09/08/2017
• Date Device Manufactured: 06/05/2017
• 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: THE 990063-020, MAPPING CATHETER
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR