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

Model Number	NRG-71-C1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
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 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.There is no suspected device failure.The reported patient complication is an inherent risk in this type of procedure.
Event or Problem Description
Baylis medical was informed of a pulmonary vein isolation (pvi) procedure in which the nrg transseptal needle was used for transseptal puncture and a complication occurred.The physician performed two transseptal punctures with the nrg needle through a sl1 sheath with no issue.The physician pulled out the nrg needle to exchange for an agilis sheath.No baylis products were used again or placed inside the patient.The physician lost access with the agilis sheath but was later able to cross again through the same puncture site.The case proceeded and later, a perforation was discovered.The patient was deemed stable and did not have to leave the catheterization lab but the procedure was aborted.The nursing staff indicated that the physician felt that the baylis nrg transseptal needle nrg needle was not responsible for the perforation.The nursing staff stated that very high contact force was observed on the mapping system throughout the procedure.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, quebec H4T 1 A1; CA H4T 1A1
• MDR Report Key: 8637312
• Report Number: 9710452-2019-00016
• Device Sequence Number: 19386017
• Product Code: DXF
• UDI-Device Identifier: 00685447000020
• UDI-Public: (01)00685447000020(17)210828(10)NGFA110918
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/23/2019

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: 08/28/2021
• Device Model Number: NRG-71-C1
• Device Lot Number: NGFA110918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/23/2019
• 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: Other