MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60SF3

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the cryoflex probe, in addition to the loose piece, was received in the quality assurance laboratory.Visual analysis noted a separation in the handle of the probe.Conclusion: medtronic is unable to determine the root cause at this time as the investigation is still in progress.A supplemental report will be filed upon completion of the investigation.

Event Description

Medtronic received information that during a case, the surgeon applied pressure to the white handle of this cryoflex probe in order to achieve the desired placement.During this manipulation of the device, the probe bent at the white handle approximately 90 degrees and broke.A small metal object fell out of the handle and into the patient's chest cavity.After approximately 20 seconds, the surgeon noticed the metal object and stopped the ablation to remove it from the patient's chest cavity.The customer continued to use the probe and it maintained expected temperatures to complete the maze procedure successfully.There were no adverse patient effects as a result of this issue.Both the metal object and the full probe were returned to medtronic for analysis.

Manufacturer Narrative

Conclusion: after investigation at medtronic it was confirmed that the loose piece is an internal component from within the cryoflex probe.It is suspected that the force exerted onto the handle of the probe is what caused the probe to break open, and subsequently caused the component to fall out.There are no current trends related to this issue.Medtronic will continue to monitor for future occurrences and trends.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6078955
• MDR Text Key: 59187863
• Report Number: 3008592544-2016-00060
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2018
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR