MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M0068311251
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	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a sacrospinous ligament fixation procedure using a capio device, the dart detached from the suture.Another capio slim device was used to complete the procedure.No patient complication was reported.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a0501 captures the reportable event of dart detachment.
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.Device code a0501 captures the reportable event of dart detachment.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 carrier was able to move in and out.After deploying the carrier, the cage was able to catch the suture.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Based on the information available and analysis results, the reported event of "dart detachment" was not confirmed.A conclusion code of no problem detected was assigned to this investigation.This conclusion was selected because it was reported that the dart detached from the suture, 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.Also, the evidence from the product record review did not identify a potential product quality issue.
Event or Problem Description
It was reported that during a sacrospinous ligament fixation procedure using a capio device, the dart detached from the suture.Another capio slim device was used to complete the procedure.No patient complication was reported.

• Brand Name: CAPIO
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 22401504
• Report Number: 2124215-2025-41947
• Device Sequence Number: 15541918
• Product Code: FHQ
• UDI-Device Identifier: 08714729257615
• UDI-Public: (01)08714729257615(17)270110(10)33191921
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 08/07/2025

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: M0068311251
• Device Catalogue Number: 831-125
• Device Lot Number: 0033191921
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/12/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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