ADVISOR? HD GRID MAPPING CATHETER, SENSOR ENABLED? D-AVHD-DF16

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for ADVISOR? HD GRID MAPPING CATHETER, SENSOR ENABLED? D-AVHD-DF16 manufactured by St. Jude Medical.

Event Text Entries

[186596133] The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10


[186596134] During the procedure, a pericardial effusion was noted. A pericardiocentesis was performed to stabilize the patient.
Patient Sequence No: 1, Text Type: D, B5


[188861411] The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information received, the cause of the reported cardiac perforation may have been procedure related. Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005334138-2020-00121
MDR Report Key9860152
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2019-12-11
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-09-16
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVISOR? HD GRID MAPPING CATHETER, SENSOR ENABLED?
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Product CodeDRF
Date Received2020-03-20
Model NumberD-AVHD-DF16
Catalog NumberD-AVHD-DF16
Lot Number7181989
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-20

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