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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ARCTIC FRONT ADVANCE PRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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MEDTRONIC, INC. ARCTIC FRONT ADVANCE PRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number AFAPRO28
Device Problem Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 02/15/2021
Event Type  malfunction  
Event Description
Balloon unable to go through sheath.Changed sheath, same problem occurred upon 2nd attempt.Balloon changed and no problem.Balloon never made it into the patient.Manufacturer response for catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation, arctic front advance pro (per site reporter).Requesting balloon be sent back for review.
 
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Brand Name
ARCTIC FRONT ADVANCE PRO
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key11452990
MDR Text Key238873111
Report Number11452990
Device Sequence Number1
Product Code OAE
UDI-Device Identifier00763000245436
UDI-Public(01)00763000245436(17)211130(10)13408
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/05/2021
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 Model NumberAFAPRO28
Device Lot Number13408
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/05/2021
Event Location Hospital
Date Report to Manufacturer03/10/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age28470 DA
Patient Weight88
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