NRG TRANSSEPTAL NEEDLE NRG-E-HF-71-C0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-22 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-71-C0 manufactured by Baylis Medical Company Inc..

Event Text Entries

[175921725] Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. However, as the baylis device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report. There is no suspected device failure. The reported patient complication is an inherent risk in this type of procedure.
Patient Sequence No: 1, Text Type: N, H10


[175921726] During an ablation procedure in which the nrg transseptal needle was used, a cardiac tamponade occurred. Following the procedure, the patient expired. During an ablation procedure for atrial fibrillation, an nrg transseptal needle was used for transseptal puncture. The patient's atrium was notably large and the physician had difficulty puncturing the septum. Transseptal puncture was achieved after four applications of rf energy using the rf needle. While the physician was manipulating a biosense webster ablation catheter in the patient's left atrium, the patient complained of a chest pain. After a blood pressure drop was observed, the patient had bradycardia and then cardiac arrest. The patient received intubation and cardiac massage, and subsequently underwent cardiac surgery. It was later reported that cardiac tamponade had been confirmed with bleeding observed from the posterior wall of the left atrium. The ablation procedure was aborted. The patient was hospitalized in a coronary care unit with the use of a percutaneous cardiopulmonary support system. Following the case on (b)(6) 2019, the patient expired on (b)(6) 2020. There is no evidence to suggest that a baylis medical device caused or contributed to the reported incident. However, as baylis medical device were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710452-2020-00002
MDR Report Key9617808
Report SourceDISTRIBUTOR
Date Received2020-01-22
Date of Report2020-01-22
Date of Event2019-12-23
Date Mfgr Received2019-12-26
Date Added to Maude2020-01-22
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 ContactDR. MEGHAL KHAKHAR
Manufacturer Street2775 MATHESON BLVD. EAST
Manufacturer CityMISSISSAUGA, ONTARIO L4W 4P7
Manufacturer CountryCA
Manufacturer PostalL4W 4P7
Manufacturer G1BAYLIS MEDICAL COMPANY INC.
Manufacturer Street2775 MATHESON BLVD. EAST
Manufacturer CityMISSISSAUGA, ONTARIO L4W 4P7
Manufacturer CountryCA
Manufacturer Postal CodeL4W 4P7
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNRG TRANSSEPTAL NEEDLE
Generic NameRF TRANSSEPTAL NEEDLE
Product CodeDXF
Date Received2020-01-22
Model NumberNRG-E-HF-71-C0
Lot NumberNGFB220419
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAYLIS MEDICAL COMPANY INC.
Manufacturer Address5959 TRANS-CANADA HIGHWAY MONTREAL, QUEBEC H4T 1A1 CA H4T 1A1


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-01-22

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