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

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Material Integrity Problem (2978)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Death (1802); ST Segment Elevation (2059); Ventricular Fibrillation (2130); Brain Injury (2219); Loss of consciousness (2418)

Event Date 08/02/2018

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, while the balloon catheter was being inserted into the sheath, the patient took a deep breath.A large amount of air was aspirated.St elevation was then observed and a backflow of blood was confirmed.The patient developed ventricular fibrillation (vf) and defibrillation was administered.The patient then went into cardiac arrest.A coronary angiogram was performed and air embolism was confirmed in the coronary artery and part of the aorta.Percutaneous cardiopulmonary support (pcps) was then attached to the patient.The patient remained unconscious.The patient left the operating room and was brought to an intensive care unit for further observation.It was indicated that the heart rate stabilized.The case was aborted and the patient was not under general anesthesia.It was further indicated that the patient has severe brain damage.The physician felt that the valve of the sheath was not as expected.Further information received indicated that the patient is off the pcps, but is suffering "grave" damage to the brain and was still being hospitalized.Additional information reported that the patient passed away.

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, while the balloon catheter was being inserted into the sheath, the patient took a deep breath.A large amount of air was aspirated.St elevation was then observed and a backflow of blood was confirmed.The patient developed ventricular fibrillation (vf) and defibrillation was administered.The patient then went into cardiac arrest.A coronary angiogram was performed and air embolism was confirmed in the coronary artery and part of the aorta.Percutaneous cardiopulmonary support (pcps) was then attached to the patient.The patient remained unconscious.The patient left the operating room and was brought to an intensive care unit for further observation.It was indicated that the heart rate stabilized.The case was aborted and the patient was not under general anesthesia.It was further indicated that the patient has severe brain damage.The physician felt that the valve of the sheath was not as expected.No further patient complications have been reported as a result of this event.(b)(6)2018: further information received indicated that the patient is off the pcps, but is suffering "grave" damage to the brain and is still being hospitalized.(b)(6)2018: additional information reported that the patient passed away.(b)(6)2018: incoming information indicated that the date of the death has not been disclosed.

Manufacturer Narrative

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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7833926
• MDR Text Key: 118797696
• Report Number: 3002648230-2018-00596
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 41670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Date Device Manufactured: 05/18/2018
• 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: 2AF284 BALLOON CATHETER
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91