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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 Problem Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2020
Event Type  malfunction  
Manufacturer Narrative
Product event summary: visual inspection of balloon catheter (2af283 lot # 58553) showed the device guide wire luer was broken.The catheter connected to the console and no system notices were received; catheter was recognized.The catheter passed the electrical integrity and performance test as per specification.In conclusion, the balloon catheter failed the inspection due to the broken guide wire luer.If information is provided in the future, a supplemental report will be issued.
 
Event Description
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 Key10482747
MDR Text Key215574236
Report Number3002648230-2020-00460
Device Sequence Number1
Product Code OAE
UDI-Device Identifier02000017010241
UDI-Public2000017010241
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100010
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 09/02/2020
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 Date01/07/2022
Device Model Number2AF283
Device Catalogue Number2AF283
Device Lot Number58553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2020
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received09/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2020
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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