MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC TORFLEX TRANSSEPTAL GUIDING SHEATH; INTRODUCER, CATHETER

Lot Number	0033514467
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a farapulse pulmonary vein isolation, a torflex transseptal guiding sheath was selected for use.When the staff member opened the device packaging, it was noted the front of the packaging tore abnormally.The staff questioned the integrity of the sterility of the product and decided to open a replacement kit.The procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
The device was returned for analysis, and a section of the packaging was returned (original packaging not returned, only udi label torn off returned).During visual inspection, no issues with sheath, dilator or guidewire were noted.The devices passed flushing tests.The reported allegation was not confirmed as although a section of the packaging was returned, it is considered insufficient evidence to conclude that there was a failure associated with the packaging.
Event or Problem Description
It was reported during a farapulse pulmonary vein isolation, a torflex transseptal guiding sheath was selected for use.When the staff member opened the device packaging, it was noted the front of the packaging tore abnormally.The staff questioned the integrity of the sterility of the product and decided to open a replacement kit.The procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICALE CIE 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: 20558552
• Report Number: 2124215-2024-67779
• Device Sequence Number: 16944172
• Product Code: DYB
• UDI-Device Identifier: 00685447005391
• UDI-Public: 00685447005391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 12/02/2024

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: 07/06/2026
• Device Lot Number: 0033514467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/24/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown