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

Model Number	TF85-32-63-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that torflex transseptal guiding sheath was selected for ablation.It was mentioned that during the preparation when the device was opened, the hub was noted to be broken in an area that could enter the patient.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
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.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.
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.No return product was received, so device specifications could not be verified.There is no evidence to suggest the device did not meet design specifications, and device failure is not suspected.Overall, the reported allegation cannot be confirmed because the device has not been returned to bsc for analysis.Dhr/service history review: a batch review was performed and dhr 37071162, 37200560 & 37199259 was reviewed.There were no non-conformances for the manufactured devices.Additional review is not required.Labeling review: the instructions for use were reviewed and it did not reveal any evidence of device off-label use or failure to follow instructions.There is no evidence that any updates to the document are required at this time.Risk review: the complaint type does not present a new or unanticipated failure type or harm.The "unable to exclude device problem" cause conclusion code was selected based on the information provided within the event description.
Event or Problem Description
It was reported that torflex transseptal guiding sheath was selected for ablation.It was mentioned that during the preparation when the device was opened, the hub was noted to be broken in an area that could enter the patient.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.

• 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: 23982157
• Report Number: 2124215-2026-00777
• Device Sequence Number: 10704361
• Product Code: DQY
• UDI-Device Identifier: 00685447005391
• UDI-Public: (01)00685447005391(17)280401(10)37513903
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/26/2026

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: 0037513903
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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