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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 Material Integrity Problem (2978); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2020
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the data files and balloon catheter afapro28 with lot number 53312 were returned and analyzed.The data files showed that the date on the file was 1 january 2001.The battery on the cpu may be depleted.The files also showed at least six applications with the returned catheter were performed without any system notice.In another file showed that system notice 50005 was received ¿the safety system has detected fluid in the catheter and stopped the injection.¿ visual inspection of the catheter showed that the traces of blood inside the balloon catheter and the coaxial connector.Smart chip verification indicated the catheter was not used for any injection.The catheter failed the performance test after triggering system notice #50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ upon connection to the console.Dissection showed the traces of the blood inside the handle and the pressure test revealed the guide wire lumen was breached and kinked at 1.209 and 2.49 inches from the tip.The compatibility issue was reproduced with the returned mapping catheter and as well as a test mapping catheter due to the kinks on the guide wire lumen.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen kink and breach.If information is provided in the future, a supplemental report will be issued.
 
Event Description
After a completed case, the balloon catheter subsequently tested out of specification per the manufacturer's investigation.
 
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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
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA   H9R 5Z8
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10521504
MDR Text Key209811064
Report Number3002648230-2020-00477
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100010/S015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/11/2020
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 Date01/05/2022
Device Model NumberAFAPRO28
Device Catalogue NumberAFAPRO28
Device Lot Number53312
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2020
Initial Date Manufacturer Received 08/21/2020
Initial Date FDA Received09/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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