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	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0510 captures the reportable event of carrier failure to retract.
Event or Problem Description
It was reported that during a transvaginal mesh procedure using a capio slim device, the needle could not be attached, and the suture thread could not be retracted.A second capio slim device was used to successfully complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: device code a0510 captures the reportable event of carrier failure to retract.Block h11: upon receipt at our quality assurance laboratory, this capio slim device underwent a thorough analysis.Visual inspection of the device did not reveal any anomalies.Upon functional inspection, the monodek and bondek sutures were able to be loaded in the device, and the carrier was able to move in and out.After deploying the carrier, the cage was able to catch both sutures, not having issues with the extension and retraction of the carrier.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Based on the information available and analysis results, the reported event of "carrier retraction problem" was not confirmed.A conclusion code of no problem detected was assigned to this investigation.This conclusion was selected because it was reported carrier retraction problem, however, after visual and functional inspections in the complaint device it was not possible to identify any evidence of either the alleged issue or any defect on the device since the carrier was able to move in and out; after deploying the carrier, the cage was able to catch both sutures, not having issues with the extension and retraction of the carrier.
Event or Problem Description
It was reported that during a transvaginal mesh procedure using a capio slim device, the needle could not be attached, and the suture thread could not be retracted.A second capio slim device was used to successfully complete the procedure.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: 22592452
• Report Number: 2124215-2025-48661
• Device Sequence Number: 18430417
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: (01)08714729838005(17)270610(10)34200498
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/10/2025

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: 0034200498
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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 Sex: Female