MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TORFLEX TRANSSEPTAL GUIDING SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION / INTRODUCER

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	02/04/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during the watchman procedure to treat atrial fibrillation torflex transseptal guiding sheath was selected for use.Upon the device prepping the stopcock broke.The procedure was completed successfully by using a different device (same model, boston scientific product).No patient complications have been reported.The product is expected to be returned.
Additional Manufacturer Narrative
Investigation summary with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of broken stopcock.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis boston scientific has made three attempts to retrieve the device however no response was received; the device is not expected to be returned; therefore, a technical analysis of the complaint device could not be completed.Based on the information provided, the damage type is the likely the result of insufficient packaging design as the root cause and storage conditions as a contributing factor.Investigation conclusion 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 and the media attached.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 during the watchman procedure to treat atrial fibrillation torflex transseptal guiding sheath was selected for use.Upon the device prepping the stopcock broke.The procedure was completed successfully by using a different device (same model, boston scientific product).No patient complications have been reported.The product is expected to be returned.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION / INTRODUCER
• 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: 24454982
• Report Number: 2124215-2026-10665
• Device Sequence Number: 13298928
• Product Code: DQY
• UDI-Device Identifier: 00685447005391
• UDI-Public: (01)00685447005391(17)280401(10)37516161
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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?: No
• 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: 03/20/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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