MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (235CM); ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	M00505510
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system was used during an endoscopic submucosal dissection (esd) procedure on (b)(6) 2026.During the procedure, one of the tacks dislodged from the patient's tissue.The suture was also tangled around the catheter.The procedure was completed with an alternate device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4,h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6 device code a0406 is being used to capture the reportable event of suture tangled.Device evaluation block h11 the device was discarded; therefore, a technical analysis could not be performed.There was no media available for analysis.The reported event of suture tangled could not be confirmed.A review was not completed of the device history records (dhr) for the device.The dhr review cannot be performed as no batch number was reported.Based on all gathered information, there is not enough evidence to determine whether the suture tangled and helix fall off was due to the physician's technique during the procedure or was related to a device malfunction.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (235CM)
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25129108
• Report Number: 3005099803-2026-01696
• Device Sequence Number: 10390732
• Product Code: PKL
• UDI-Device Identifier: 00191506049164
• UDI-Public: (01)00191506049164
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 06/02/2026

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: M00505510
• Device Catalogue Number: M00505510
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female