MAUDE Adverse Event Report: MEDTRONIC, INC. (MINNEAPOLIS, MN 55447) CARDIOBLATE CRYOFLEX; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60SF2

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

When using cryo equipment for maze procedure, the cryo handpiece broke and fell apart after the first use.New handpiece had to be given up onto field, which functioned fine.First handpiece was wrapped in biohazard bag with all labeling and packaging and given to front desk.Medtronic cardioblate cryoflex surgical ablation probe ref#60sf2.

• Brand Name: CARDIOBLATE CRYOFLEX
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC. (MINNEAPOLIS, MN 55447); 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 5415940
• MDR Text Key: 37635334
• Report Number: 5415940
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR