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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
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MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE Back to Search Results
Model Number 60SF2
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/23/2019
Event Type  Injury  
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 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.
 
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 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.
 
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.
 
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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
MDR Report Key8695050
MDR Text Key147849602
Report Number3008592544-2019-00021
Device Sequence Number1
Product Code OCL
UDI-Device Identifier00763000114619
UDI-Public00763000114619
Combination Product (y/n)N
PMA/PMN Number
K123733
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/07/2021
Device Model Number60SF2
Device Catalogue Number60SF2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Date Manufacturer Received08/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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