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

Model Number	M0068318261
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of bullet 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" 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.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 "unable to exclude device problem", as the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.
Event or Problem Description
It was reported that during a sacrospinous ligament fixation procedure using a capio slim device, the bullet detached from the suture and was retained in the patient.There were attempts made to retrieve the bullet; however, these were unsuccessful.The procedure was completed and there were no further patient complications were reported.
Additional Manufacturer Narrative
Block h2: blocks b5 and e1: initial reporter phone have been updated based on the additional information received.Correction to blocks h6: method codes and h11 (labeling review added in the investigation analysis summary below).Block h6: imdrf device code a0501 captures the reportable event of bullet 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.The reported patient symptom of unretrieved device fragments is acknowledged within the ifu and are not related to off-label use or failure to follow instructions.The reported patient symptom of unretrieved device fragments is a known risk associated with this device type and indicated as such in the instructions for use.A risk review was completed and confirmed that the event of "dart detachment of device or device component" and "unretrieved device fragments" were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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 "unable to exclude device problem", as the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.
Event or Problem Description
It was reported that during a sacrospinous ligament fixation procedure using a capio slim device, the bullet did not engage with the receiving mechanism and detached from the suture, resulting in the bullet being retained in the patient.The suture broke on the right side of the patient right at the dart.Attempts were made to retrieve the bullet; however, these attempts were unsuccessful.The procedure was completed using another suture with the same capio device, and no further 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: 24651549
• Report Number: 2124215-2026-15570
• Device Sequence Number: 15901974
• Product Code: PWI
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(10)37292091
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 06/01/2026

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: 0037292091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 05/08/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/13/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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