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 Ventricular Fibrillation (2130); Cardiac Perforation (2513)

Event Date 02/24/2021

Event Type  Death  

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 sheath fell to the right atrium and moved from the right to left atrium.The patient's blood pressure dropped and cardiac tamponade was observed.Drainage was performed; however, ventricular fibrillation (vf) occurred.Shocks were performed and the vf stopped after four shocks.The blood continued despite drainage and the patient was moved to an intensive care unit.The patient was unconscious.As bleeding continued several hours later, a surgical operation was performed.The left atrium could not be sutured and so bypass surgery was attempted but the hole could not be repaired.The patient then went into cardiac arrest.Heart massage was performed by hand, but the right ventricle was torn.The patient then died.It was noted that the patient moved considerably during the operation.

• 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: 11423995
• MDR Text Key: 235012293
• Report Number: 3002648230-2021-00096
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2021

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: 11/24/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010460461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/05/2021
• Date Device Manufactured: 11/24/2020
• 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: 2ACH20 MAPPING CATHETER, AFAPRO28 BALLOON CATHETER
• Patient Outcome(s): Death; Life Threatening; Required Intervention