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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 2AF284
Device Problem Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, the mapping catheter kinked inside the patient.The mapping catheter was replaced which resolved the issue.Then, when the balloon catheter was removed, air was observed.The balloon catheter was re-introduced which resolved the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.
 
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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 Key10532174
MDR Text Key206967802
Report Number3002648230-2020-00479
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100010/S015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2020
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 Date11/19/2020
Device Model Number2AF284
Device Catalogue Number2AF284
Device Lot Number11078
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/25/2020
Initial Date FDA Received09/14/2020
Date Device Manufactured11/20/2019
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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