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	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a sacrospinous ligament fixation procedure using a capio slim device, the carrier failed to retract.After multiple unsuccessful attempts to throw the suture using a capio device, the physician decided not to use the capio device to place the final suture and instead manually located the sacrospinous ligament and performed traditional (non-device) suturing to complete the procedure.No patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a0510 captures the reportable event of carrier failure to retract.
Additional Manufacturer Narrative
Block h11: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual inspection of the device did not have any visual damage/defect.During functional inspection, the carrier was able to move in and out; after deploying the carrier, the cage was able to catch the suture.A review of the device history record (dhr) was performed and confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Additionally, a risk review was completed and confirmed that the event of "carrier retraction problem" 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 available and analysis results, the reported allegations of carrier failure to retract could not be confirmed through product analysis.A conclusion code of device problem excluded was assigned to this investigation since the investigation findings clearly confirm that there was no problem with the device.Device code a0510 captures the reportable event of carrier failure to retract.
Event or Problem Description
It was reported that, during a sacrospinous ligament fixation procedure using a capio slim device, the carrier failed to retract.After multiple unsuccessful attempts to throw the suture using a capio device, the physician decided not to use the capio device to place the final suture and instead manually located the sacrospinous ligament and performed traditional (non-device) suturing to complete the procedure.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: 24030666
• Report Number: 2124215-2026-01721
• Device Sequence Number: 18384860
• Product Code: PWI
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(10)37068872
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 03/09/2026

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: 0037068872
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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 Age: 73 YR
• Patient Sex: Female