MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO SLIM; SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH

Model Number	M0068318261
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of bullet dart detachment.
Event or Problem Description
It was reported that a capio slim device was used during a vault suspension procedure on (b)(6) 2026.During the procedure, a non-boston scientific suture did not penetrate the intended ligament on the patient's right side.The surgeon replaced the suture and attempted to rethrow it.At that time, the surgeon observed that the dart was no longer attached to the end of the suture.The device cage was opened by bending the metal housing, at which point the detached dart was located within the device with a very small portion of suture remaining attached (less than 1 cm).The procedure was completed using another capio slim with a different suture.No patient complications were reported.

• Brand Name: CAPIO SLIM
• Common Device Name: SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24834991
• Report Number: 2124215-2026-19438
• Device Sequence Number: 18697106
• Product Code: PWI
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(10)36102855
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172060
• 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): 05/19/2026

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: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0036102855
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 03/19/2025
• 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: 56 YR
• Patient Sex: Female
• Patient Race: White