MAUDE Adverse Event Report: MEDTRONIC ARTIC FRONT ADVANCE; CRYOABLATION

Model Number ZAF284

Device Problems Retraction Problem (1536); Material Rupture (1546)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 07/08/2016

Event Type  Injury  

Event Description

During cryoablation of the pulmonary veins, the balloon ruptured (both inner and outer balloons) dispelling nitrous oxide into the left ventricle, patient blood pressure and oxygen saturations dropped.Balloon would not retract into the sheath.

• Brand Name: ARTIC FRONT ADVANCE
• Type of Device: CRYOABLATION
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5802580
• MDR Text Key: 49985302
• Report Number: MW5063478
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZAF284
• Device Lot Number: 67615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100