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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4 lot number: there were two lot numbers provided for capio slim.At this time, lot number 0035389425 has been selected.A supplemental report will be submitted if additional information becomes available.Block b3 date of event: the exact event onset date is unknown.The provided event date of april 8, 2026, was chosen as a best estimate based on the date of service.Block h6: imdrf device code a0501 captures the reportable event of bullet dart detachment.
Event or Problem Description
It was reported that during a sacrospinous ligament fixation procedure using a capio slim, the bullet detached from the suture on two separate monodek sutures.Initially, the bullet was thought to be lodged in the pelvis; however, it was later determined to be retained within the channel on the capture side of the device.The procedure was completed using another capio device.There were no patient complications reported.Note: this manufacturer report pertains to the first of two devices used during the procedure.

• 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: 25127208
• Report Number: 2124215-2026-25107
• Device Sequence Number: 10738072
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: (01)08714729838005(17)271129(10)35389425
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: M0068318250
• Device Catalogue Number: M0068318250
• Device Lot Number: 0035389425
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 11/29/2024
• 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 Age: 65 YR
• Patient Sex: Female