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); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/03/2022

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 cryoablation procedure, the system was aspirated, then inserted into the left atrium.The first pulmonary vein (pv) was cannulated, the balloon catheter was inflated and contrast was injected to check the occlusion, however there was an anomalous dispersion of the contrast so the system was removed and an echocardiogram confirmed a pericardial effusion that developed into a tamponade.The patient also became hypotensive.  the case was aborted while the patient was under general anesthesia.A coagulant was administered and a pericardiocentesis was performed draining two liters of blood.The patient went into cardiac arrest multiple times.It was determined that the patient required thoracic surgery.Upon transfer to surgery, the patient went into cardiac arrest and required a cardiac massage until surgery could be performed.The patient returned to spontaneous rhythm with a normal blood pressure.In surgery, a perforation was found on the upper portion of the left atrium, which was then surgically closed.The patient was taken to the intensive care unit (icu) for recovery.Upon waking up, the patient maintained normal cognitive abilities. 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: 13711601
• MDR Text Key: 286866085
• Report Number: 3002648230-2022-00095
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010946221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Date Device Manufactured: 11/23/2021
• 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: AFAPRO28 BALLOON CATHETER, 2ACH20 MAPPING CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male