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U.S. Department of Health and Human Services

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

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MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number 2AF283
Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the data files and 2af283 balloon catheter with lot 56473 were returned and analyzed.The data files showed the balloon catheter was used for at least six applications on the date of the event without issue.The data files also showed system notice #50005 (the safety system has detected fluid in the catheter and stopped the injection) triggered several times on the date of the event.Visual inspection showed that the catheter was intact with no apparent issues.The balloon catheter failed the performance test due to system notice #50005 upon application of the vacuum.A fluid was seen in the coaxial connector and the pressure test showed a leak through the tip.Catheter dissection and pressure testing showed a guide wire lumen breach.Further analysis showed a guide wire lumen breach, twist, and kink at the balloon segment in several points (1.35 , 1.36 and 086 inches) proximal from the tip.In conclusion, the balloon catheter failed the returned product inspection due to a guide wire lumen twist, breach and kink.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 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 Key10726964
MDR Text Key212764755
Report Number3002648230-2020-00561
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 10/23/2020
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 Date06/05/2022
Device Model Number2AF283
Device Catalogue Number2AF283
Device Lot Number56473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2020
Initial Date Manufacturer Received 10/02/2020
Initial Date FDA Received10/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2020
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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