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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

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MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number AFAPRO28
Device Problems Device Contamination with Body Fluid (2317); Material Integrity Problem (2978); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that following a successful cryo ablation procedure, blood was observed in the console.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the balloon catheter afapro28 with lot 56405, was returned and analyzed.Visual inspection showed traces of blood within the inner balloon.Smart chip verification indicates that the catheter has not been used.A system notice, 50005, indicating ¿the safety system detected fluid in the catheter and stopped the injection¿ was received.A pressure test of the catheter showed a leak though the tip.The dissection and pressure test showed inner balloon breach.Further analysis showed a guide wire lumen breach within the balloon segment and broken tc wires at the soldering point within the balloon segment.The reported issue of visual blood was confirmed the testing.The reported catheter failed the returned product inspection due to, a guide wire lumen twist and breach, as well as an inner balloon breach.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER
Type of Device
PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA  H9R 5Z8
MDR Report Key10505755
MDR Text Key206166565
Report Number3002648230-2020-00467
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
PMA/PMN Number
P100010/S015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/09/2022
Device Model NumberAFAPRO28
Device Catalogue NumberAFAPRO28
Device Lot Number56405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Initial Date Manufacturer Received 08/18/2020
Initial Date FDA Received09/08/2020
Supplement Dates Manufacturer Received09/22/2020
Supplement Dates FDA Received10/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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