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	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f1901 captures the reportable event of additional surgical intervention.Imdrf device code a050502 captures the reportable event of device misfired.
Event or Problem Description
It was reported that during sacrospinous ligament fixation procedure, five capio slim devices were used for pelvic organ prolapse.During the procedure, the devices did not fire properly.Hospital admission was required for the patient for additional surgical intervention.No patient complications were reported.Note: this manufacturer report pertains to the second of five devices used during the procedure.
Event or Problem Description
It was reported that during sacrospinous ligament fixation procedure, five capio slim devices were used for pelvic organ prolapse.During the procedure, the devices did not fire properly.Hospital admission was required for the patient for additional surgical intervention.No patient complications were reported.Note: this manufacturer report pertains to the second of five devices used during the procedure.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1901 captures the reportable event of additional surgical intervention.Imdrf device code a050502 captures the reportable event of device misfired.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 "device misfire" 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 "cause not established", as the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.

• 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: 25194154
• Report Number: 2124215-2026-26532
• Device Sequence Number: 8889829
• Product Code: PWI
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(10)34886311
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0034886311
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 09/19/2024
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 162 LB
• Patient Race: White