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	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that, during a sacrospinous ligament fixation (vaginal prolapse repair) procedure using a capio slim device, 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 dart detached and fell into the patient.Despite using an x-ray imaging and peeling the ligament layers, the surgical team was unable to locate or retrieve the dart, which remained in the sacrospinous ligament.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
H11: d4: model number and catalog number have been updated based on the additional information received.D4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.H6: device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that, during a sacrospinous ligament fixation (vaginal prolapse repair) procedure using a capio slim device, 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 dart detached and fell into the patient.Despite using an x-ray imaging and peeling the ligament layers, the surgical team was unable to locate or retrieve the dart, which remained in the sacrospinous ligament.The procedure was completed with another of the same device.No 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: 22192124
• Report Number: 2124215-2025-37454
• Device Sequence Number: 20972841
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: (01)08714729838005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 06/25/2026

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
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 05/26/2026
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 09/18/2025; 06/25/2026
• 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: Female