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	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ligament hysteropexy procedure using a capio slim, the device failed to properly anchor the suture.It cut the suture thread and retained the needle within the tissue.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of dart detachment.
Additional Manufacturer Narrative
Correction to blocks b5 (below) and h6: impact codes - the suture broke during deployment on the patient's left side.The procedure was not completed.Block h6: imdrf device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that during a ligament hysteropexy procedure using a capio slim device, the device failed to properly anchor the suture.It was also reported that after loading the dart into the carrier, the suture was pulled back and tensioned along the capio handle.After the device was fully deployed, the suture thread broke on the patient's left side, and the suture needle remained within the tissue.As a result of this, the procedure was not completed.No patient complications were reported.
Additional Manufacturer Narrative
Block h11: correction to block e1: initial reporter phone and initial reporter email.Block h6: imdrf device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that during a ligament hysteropexy procedure using a capio slim device, the device failed to properly anchor the suture.It was also reported that after loading the dart into the carrier, the suture was pulled back and tensioned along the capio handle.After the device was fully deployed, the suture thread broke on the patient's left side, and the suture needle remained within the tissue.As a result of this, the procedure was not completed.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: 22720553
• Report Number: 2124215-2025-51149
• Device Sequence Number: 15736311
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: (01)08714729838005(17)270522(10)34072662
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 0034072662
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 02/02/2026
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/22/2025; 02/26/2026
• Date Device Manufactured: 05/22/2024
• 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
• Patient Age: 49 YR
• Patient Sex: Unknown