NRG TRANSSEPTAL NEEDLE NRG-E-HF-98-C1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-26 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-98-C1 manufactured by Baylis Medical Company Inc..

Event Text Entries

[139958230] 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


[139958231] The nrg transseptal needle (nrg needle) and torflex transseptal guiding sheath (tfk) were used for transseptal puncture in a procedure. The physician noticed an effusion on intracardiac echocardiography (ice) following the first and during the second transseptal puncture. The physician used an agilis sheath and 98 cm c1 nrg needle to perform the first transseptal puncture. The physician was able to puncture across the septum easily in a safe position in the middle of the septum via ice. The physician then prepared for the second transseptal using the 45 degree tfk and 71 cm c1 nrg needle. The physician had some difficulty getting into the correct position and was in a very posterior and low position with the sheath and dilator. The nrg needle was never exposed in this position. The physician then torqued the sheath and needle into a better tenting position and applied rf energy for 1 second (constant). Before putting anything across the septum other than the nrg needle, the physician scanned ice and noticed a large effusion developing. The physician monitored the effusion for a few minutes and decided in consultation with another physician that a pericardial tap was required. Once tapped, the physician noted that the blood was very dark and most likely from the right ventricle (rv). The physician noted it was very unlikely that the complication would have occurred as a result of transseptal puncture. It was the opinion of the physician that while putting the coronary sinus (cs) catheter in place, a small effusion may have been caused that grew much worse after heparinizing, as this was precisely when the effusion was noticed on ice. 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710452-2019-00008
MDR Report Key8454004
Report SourceHEALTH PROFESSIONAL
Date Received2019-03-26
Date of Report2019-03-26
Date of Event2019-02-25
Date Mfgr Received2019-02-25
Date Added to Maude2019-03-26
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 Received2019-03-26
Returned To Mfg2019-03-05
Model NumberNRG-E-HF-98-C1
Lot NumberNGFG101218
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
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. Required No Informationntervention 2019-03-26

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