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 Abnormal Blood Gases (1034); Bradycardia (1751); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 04/13/2022

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, bradycardia occurred with the patient so an intracardiac echocardiogram was performed and cardiac tamponade was observed leading to the procedure to be aborted.The patient's blood pressure decreased.Drainage of the tamponade and a blood transfusion was performed.The patient's blood ph decreased and the patient was intubated.The bleeding would not stop and the patient's blood pressure would not increase requiring the patient to be put on percutaneous cardiopulmonary support (pcps).The patient's bleeding stopped and the patient's blood pressure increased after the pcps and the patient was admitted to the intensive care unit (icu).The following day, the patient was taken off of the pcps and later was moved from the icu.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14187524
• MDR Text Key: 289879401
• Report Number: 3002648230-2022-00179
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2022
• 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, 2ACH20 MAPPING CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female