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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 Problem Gas/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2020
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 balloon catheter was difficult to insert.Air was introduced when attempting to insert the balloon catheter with force.The balloon catheter was removed, massaged, folded, and inflation attempted outside the body all without resolution.The balloon catheter was replaced 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 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 Key10018967
MDR Text Key195752693
Report Number3002648230-2020-00254
Device Sequence Number1
Product Code OAE
UDI-Device Identifier00763000245436
UDI-Public00763000245436
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 Physician
Type of Report Initial
Report Date 05/01/2020
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 Date11/26/2020
Device Model NumberAFAPRO28
Device Catalogue NumberAFAPRO28
Device Lot Number19878
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2020
Initial Date FDA Received05/01/2020
Date Device Manufactured11/27/2019
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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