MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 106A3

Device Problem Leak/Splash (1354)

Patient Problems Ventricular Fibrillation (2130); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/02/2021

Event Type  Injury  

Event Description

During a cryotherapy atrial fibrillation ablation procedure, the medtronic cryoconsole being utilized reported an error message which led to troubleshooting interventions.Shortly after, the patient's cardiac monitor revealed a ventricular fibrillation rhythm.A code blue was called, chest compressions were performed, and eight shocks were delivered, per acls guidelines.Cardiac rhythm was normalized.Upon removal of the balloon, it was examined and determined to have a leak.The physician concluded that the abnormal heart rhythm was likely caused by nitrous oxide released through the leak.The patient required a subsequent left cardiac catheterization procedure for st elevation and was stabilized and transferred to the icu.

• Brand Name: MEDTRONIC CRYOCONSOLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea st. ne; mounds view MN 55112
• MDR Report Key: 13002069
• MDR Text Key: 282297242
• Report Number: MW5106016
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 106A3
• Device Catalogue Number: 106A3GEN V ROHS
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC ARCTIC ADVANCE PRO AFAPRO28, LOT 14543 USE BY 7/26/2022; STRYKER STEERABLE INTRODUCER SHEATH 12F X 65 CM, LOT 0000174872, EXP 02/28/2022
• Patient Outcome(s): Life Threatening; Hospitalization; Other; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White