MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Tissue Helix; Endoscopic Tissue Approximation Device

Model Number	M00505460
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001); Discomfort (2330)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a tissue helix was used during a procedure on (b)(6) 2026.During the procedure, the helix had difficultly removing from the patients tissue about 5 to 7 times, taking an extra 1 to 2 minutes to untwist from the tissue.As a result, the physician used a new helix and continued the procedure.The second helix was also difficult to remove from the patient's tissue.The procedure was completed with the second helix.It is reported that as a result of this event, the patient experienced discomfort and pain, physician believes that the patient has a perforation, medical intervention was deemed necessary but uncertain what was done.No further information has been obtained despite good faith effort.This is the second of two tissue helixes used in the same procedure.
Additional Manufacturer Narrative
Block h6 imdrf code f19 is being used to capture the unexpected medical intervention.Imdrf code a150207 is being used to capture helix difficult to remove.Imdrf code e2114 is being used to capture perforation.

• Brand Name: Tissue Helix
• 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, 02 ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50612700
• Report Number: 3005099803-2026-03636
• Device Sequence Number: 21518363
• Product Code: OCW
• UDI-Device Identifier: 00191506060053
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K181141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00505460
• Device Catalogue Number: M00505460
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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 Sex: Unknown