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

Model Number	M0068318250
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that, during the use of a capio slim device, the suture detached from the dart during surgery.The physician used the standard technique during deployment of the suture.An attempt was made to recover the dart, but it could not be found.It, along with part of the suture, remained in the patient.The procedure was then cancelled.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a0501 captures the reportable event of dart detachment.Block h11: the complaint device was not returned; therefore, no physical or visual analysis could be performed.As a result, the reported device performance allegation could not be confirmed.The device history record (dhr) confirmed that the device met all material, assembly and performance specification.A risk review was completed and confirmed that the event of "dart detachment of device or device component and unretrieved device fragments (udf)" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The impact code of "cancelled/rescheduled - post sedation/sedation unknown" is subsequent event of the primary anticipated event.A review of the device instructions for use (ifu) was completed and confirmed that the reported events are anticipated within the product ifu.There is no evidence of device misuse per the ifu, nor is there any indication of issues with the translation, wording, or graphical content of the ifu/labeling.Based on the information provided, the most probable cause of the reported issue could not be determined due to a lack of evidence, and in the absence of device evaluation or objective evidence, the most probable causes that may have contributed to the event remain unknown; therefore, this complaint is assigned an investigation conclusion code of "cause not established", as the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.

• 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: 25692595
• Report Number: 2124215-2026-35498
• Device Sequence Number: 9669607
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: (01)08714729838005(17)281026(10)37803592
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: M0068318250
• Device Catalogue Number: M0068318250
• Device Lot Number: 0037803592
• 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: 06/08/2026
• Initial Report FDA Received Date: 07/02/2026
• Date Device Manufactured: 10/27/2025
• 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 Sex: Unknown