MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. SUREFLEX STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	TSK0005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	03/16/2023
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
During the atrial septal puncture a nrg transseptal needle and sureflex steerable guiding sheath were selected for use.It was reported that the roof part of the right atrium was damaged, resulting in cardiac tamponade.Pericardiocentesis was performed under echo guide, however, the bleeding did not stop.The patient was transferred to another hospital.It was suspected that the damage noted in the right atrium was due to the radiofrequency transseptal needle, but it was not confirmed.When routine left atrial angiography was performed, it was found out that cardiac tamponade occurred due to contrast media accumulating in the pericardium and not in the left atrium.

• Brand Name: SUREFLEX STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal qc 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 Key: 16743277
• Report Number: 2124215-2023-17646
• Device Sequence Number: 6540018
• Product Code: DYB
• UDI-Device Identifier: 00685447006220
• UDI-Public: 00685447006220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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 Date: 03/02/2024
• Device Model Number: TSK0005
• Device Lot Number: SSFA041122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown