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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a sacrospinous ligament vault fixation procedure for vaginal vault prolapse using a capio slim, the device wouldn't capture the needle.A second capio slim was used; however, this device would not capture the needle either.The vault fixation procedure was then cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.The physician will wait and see how the patient heals and then decide if a further procedure is required.Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 2124215-2025-60161 for the first capio slim device.
Additional Manufacturer Narrative
Block h6: impact code f1001 captures the reportable event of procedure cancelled.
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 reveal any damages/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.Based on the information available and analysis results, the reported allegations of the cage not catching the needle could not be confirmed through product analysis.A conclusion code of no problem detected was assigned to this investigation since 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.Correction to block b1: adverse event/product problem.Block h6: impact code f1001 captures the reportable event of procedure cancelled.
Event or Problem Description
It was reported that during a sacrospinous ligament vault fixation procedure for vaginal vault prolapse using a capio slim, the device wouldn't capture the needle.A second capio slim was used; however, this device would not capture the needle either.The vault fixation procedure was then cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.The physician will wait and see how the patient heals and then decide if a further procedure is required.Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 2124215-2025-60161 for the first capio slim 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: 22911812
• Report Number: 2124215-2025-60165
• Device Sequence Number: 15769684
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: (01)08714729838005(17)270522(10)34072662
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: M0068318250
• Device Catalogue Number: M0068318250
• Device Lot Number: 0034072662
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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: Other
• Patient Sex: Female