MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

Lot Number	0034012199
Medical Device Problem Codes	Break (1069); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
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 has been reported that an bmc transseptal sheath was selected for ablation.During preparation, the side port of the stopcock broke off at the connection to the tubing.Thus, a new bmc transseptal sheath was used, and the procedure was completed successfully.No patient complication was reported.The device is not returning for analysis (disposed).No other issues were noted.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20347311
• Report Number: 2124215-2024-60162
• Device Sequence Number: 8053647
• Product Code: DYB
• UDI-Device Identifier: 00685447003380
• UDI-Public: 00685447003380
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2026
• Device Lot Number: 0034012199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/01/2024
• Date Device Manufactured: 08/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown