MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. NRG TRANSSEPTAL NEEDLE; RF TRANSSEPTAL NEEDLE

Model Number	NRG-HF-71-C1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/06/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release.There is no suspected device failure.There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as the baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
Event or Problem Description
Following a watchman procedure in which the nrg transseptal needle was used for a transseptal puncture, a patient expired.The patient had a history of anemia, previous bleeds, and at the time had a very low hemoglobin level.Prior to the procedure, the physician noted a baseline effusion in the patient.The physician used the nrg needle to successfully go transseptal, but then lost access.The physician went transseptal a second time.While preparing for the watchman procedure, the patient's blood pressure began to drop.The physician studied the effusion continuously and determined there was no increase from the baseline.The room was cleared and the physician inserted a heart cath.Studies showed a possible clot and severe plaque buildup in the right coronary artery.The physician chose to insert a pacemaker and an impella device.The physician then called off the operating room staff.The physician took the patient off the pacemaker and stated that the patient was stable.The patient expired later that night.There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as the baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: RF TRANSSEPTAL NEEDLE
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, H4T 1 A1; CA H4T 1A1
• MDR Report Key: 8942504
• Report Number: 9710452-2019-00022
• Device Sequence Number: 18914373
• Product Code: DXF
• UDI-Device Identifier: 00685447000211
• UDI-Public: (01)00685447000211(17)220228(10)NGFB180319
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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 Date: 02/28/2022
• Device Model Number: NRG-HF-71-C1
• Device Lot Number: NGFB180319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death