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

Model Number	M0068318250
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of dart detachment.Impact code f2301 captures the reportable event of using cooper forceps to retrieve the dart.
Event or Problem Description
It was reported that during a procedure using a capio slim device, the suture was inadvertently cut, resulting in the needle and thread temporarily remaining inside the patient.A subsequent computed tomography (ct) scan identified the location of the dart, which was successfully removed using cooper forceps without the need for additional invasive intervention.No further patient complications reported.
Additional Manufacturer Narrative
Block h11: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual inspection of the device revealed that the cage was detached, but not fully.Additionally, it was noted that the suture did not return for analysis.Based on the information available and analysis results, the reported allegations of the dart detaching could not be confirmed through product analysis.Additionally, the reported patient symptom of unretrieved device fragment is a known risk associated with the use of a capio device and it is noted as such in the device instructions for use.A conclusion code of cause not established was assigned to this investigation since the suture did not return to perform the analysis and the investigation findings did not lead to a clear conclusion about the cause of the failures.Furthermore, during inspection, it was noted that the cage did not fully detach.The issue may have been caused by operational factors, including the application of excessive force.It is possible that manipulation during the procedure contributed to the incomplete detachment of the cage, the most probable cause of adverse event related to procedure is selected.Block h6: device code a0501 captures the reportable event of dart detachment.Impact code f2301 captures the reportable event of using cooper forceps to retrieve the dart.
Event or Problem Description
It was reported that during a procedure using a capio slim device, the suture was inadvertently cut, resulting in the needle and thread temporarily remaining inside the patient.A subsequent computed tomography (ct) scan identified the location of the dart, which was successfully removed using cooper forceps without the need for additional invasive intervention.No further patient complications 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: 23441711
• Report Number: 2124215-2025-75898
• Device Sequence Number: 20970428
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: (01)08714729838005(17)270711(10)34412314
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: M0068318250
• Device Catalogue Number: M0068318250
• Device Lot Number: 0034412314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown