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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY
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BAYLIS MEDICAL COMPANY INC. NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY Back to Search Results
Lot Number NGFD140323
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Arrest (1762)
Date of Event 11/08/2023
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event or Problem Description
It was reported that a nrf rf needle was selected for use during a watchman procedure.Physician was dragging the nrg needle from superior vena cava into septum.Then, patient went into asystole.Compressions started.A temporary pacemaker was inserted.Thus, the watchman procedure continued and it was completed successfully.The temp pacemaker was left in place.No other patient complications were noted.The device is not expected to be returned for analysis (disposed).The patient is fully recovered.The current status is unknown.No issue was noted with the nrg needle.The septum was crossed with no issues after the intervention.There were two attempts to cross the septum, and rf was applied once, with the same nrg needle.Nothing unusual about the patient anatomy was noted.In the physicians opinion, the device contributes to the patient complication, since the patient went asystole when trying to cross the septum.
 
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Brand Name
NRG TRANSSEPTAL NEEDLE
Common Device Name
CATHETER, SEPTOSTOMY
Manufacturer (Section D)
BAYLIS MEDICAL COMPANY INC.
5959 trans-canada highway
montreal H4T 1 A1
CA  H4T 1A1
Manufacturer (Section G)
BAYLIS MEDICAL COMPANY INC.
5825 explorer drive
mississauga, on L4W 5 P6
CA   L4W 5P6
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key18237579
Report Number2124215-2023-64330
Device Sequence Number7160585
Product Code DXF
UDI-Device Identifier00685447000211
UDI-Public00685447000211
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K073326
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date07/13/2025
Device Lot NumberNGFD140323
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/08/2023
Initial Report FDA Received Date11/30/2023
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured03/29/2023
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Unknown
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening; Required Intervention;
Patient Age74 YR
Patient SexUnknown
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