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

Model Number	60SF2
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return of the device has been requested from the customer and is currently pending confirmation of return.Investigation is ongoing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of the 60sf2 cryocath probe, after performing 2 one-minute freezes and 1 two-minute freeze, the probe broke and fell into the patient.The customer had used warm saline to defrost the probe.The probe was retrieved by forceps with no tissue damage.There was no difficulty retrieving the broken piece of the probe.No adverse patient effects were reported.
Additional Manufacturer Narrative
Conclusion: the bellows have been manipulated beyond the design and or material capabilities.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of the 60sf2 cryocath probe, after performing 2 one-minute freezes and 1 two-minute freeze, the probe broke and fell into the patient.The customer had used warm saline to defrost the probe.The probe was retrieved by forceps with no tissue damage.There was no difficulty retrieving the broken piece of the probe.No adverse patient effects were reported.
Additional Manufacturer Narrative
Visual analysis of the returned device confirmed a section of the heat-exchanger broken off.The investigation is currently ongoing.Following completion of the investigation, conclusion will be provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Common Device Name: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 8695050
• Report Number: 3008592544-2019-00021
• Device Sequence Number: 16715874
• Product Code: OCL
• UDI-Device Identifier: 00763000114619
• UDI-Public: 00763000114619
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2021
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 06/26/2019; 08/22/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/23/2019; 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention