MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TORFLEX TRANSSEPTAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	TF85-32-63-55
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bmc transseptal sheath was selected for use.During the preparation it was mentioned that the stopcock broke when the device was dropped on the table.No leak was noted nor any damage was noted when removed from the package.Thus, the device was replaced and the procedure was completed successfully.No patient complication was reported.The device is not expected to be return for analysis.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.However, the reported allegations are confirmed based on the media provided within the event description and details.Based on the information provided within the event description and the media attached, the cause traced to device design cause code was selected specifically for the design of the primary packaging.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24508285
• Report Number: 2124215-2026-12090
• Device Sequence Number: 10510201
• Product Code: DYB
• UDI-Device Identifier: 00685447005407
• UDI-Public: (01)00685447005407(17)271201(10)36501139
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102948
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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 Model Number: TF85-32-63-55
• Device Catalogue Number: TF85-32-63-55
• Device Lot Number: 0036501139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown