MAUDE Adverse Event Report: MEDTRONIC ARTIC CRYOABLATION BALLOON; CRYO BALLOON

Model Number REF 2AFAST28

Device Problem Material Rupture (1546)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 01/22/2016

Event Type  Injury  

Event Description

Patient was having an a-fib procedure.Patient was intubated prior to start of procedure.Cryoablation was in progress in the right pulmonary vein was at 29 sec of ablation when the cryo balloon ruptured.Cryo system immediately went in aspiration mode to withdraw the nitrogen that is in the balloon.Ntg was release into the patient's heart.Patients bp and hr dropped and went into v-fib.Was defibrillated times 3 then went into pea and cpr was started and epi given, post second dose of epi patient went into normal sinus rhythm with a pulse.Dobutamine gtt was infusing for 3 minutes and then discontinued due to stable bp.Patient sedation lightened with patient opening eyes and moving extremities.Anesthesia then increased sedation and procedure continued.

• Brand Name: ARTIC CRYOABLATION BALLOON
• Type of Device: CRYO BALLOON
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5403656
• MDR Text Key: 37383455
• Report Number: MW5059828
• Device Sequence Number: 1
• Product Code: OAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 2AFAST28
• Device Lot Number: 57551
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 117