MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TORFLEX TRANSSEPTAL GUIDING SHEATH; SEE H11

Model Number	TF85-32-63-45
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a: common device name: catheter, percutaneous / dilator, vessel, for percutaneous catheterization / introducer, catheter; reported here as the common device name exceeded the character limit for designated field.The device has not been received for analysis.Upon receipt and 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.
Event or Problem Description
It was reported that bmc transseptal sheath was selected for use.During preparation when the device was unpacked the stopcock assembly was noted to be broken.Thus, the device was replaced and the procedure was completed successfully.No patient complication was reported.The device is expected to be return for analysis.
Additional Manufacturer Narrative
D2a: common device name: catheter, percutaneous / dilator, vessel, for percutaneous catheterization / introducer, catheter; reported here as the common device name exceeded the character limit for designated field.The device has been received for analysis.The reported allegations are confirmed via analysis done to the returned device.The dhr files associated with the sheath manufacturing lot vsaa280323, were reviewed and did not show any evidence manufacturing caused or contributed to the event.There was a deviation related to the application of glue.The cause traced to device design cause code was selected specifically for the design of the primary packaging (die-cut card), based on the information provided within the event description.Additionally, previous product record reviews for complaints with this failure mode show no signs of systemic manufacturing issues that would have caused the complaint, further supporting this root cause.
Event or Problem Description
It was reported that bmc transseptal sheath was selected for use.During preparation when the device was unpacked the stopcock assembly was noted to be broken.Thus, the device was replaced and the procedure was completed successfully.No patient complication was reported.The device has been received at boston scientific post market laboratory.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: SEE H11
• 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: 23907825
• Report Number: 2124215-2025-93433
• Device Sequence Number: 10016214
• Product Code: DQY
• UDI-Device Identifier: 00685447005391
• UDI-Public: (01)00685447005391(17)280401(10)37516161
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/25/2026

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: TF85-32-63-45
• Device Catalogue Number: TF85-32-63-45
• Device Lot Number: 0037516161
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown