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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that, during a sacrospinous ligament suspension using a capio slim device, when the physician threw the suture, the dart detached.An x-ray was performed to see if dart detached inside the patient; however, it was not visible on x-ray.The physician assumed that the dart got caught in the device.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that, during a sacrospinous ligament suspension using a capio slim device, when the physician threw the suture after deployment, the dart detached.The suture was caught but the dart fell inside the patient.An x-ray was performed to locate the dart; however, the physician was unable to locate the dart.The dart was left inside the patient.The procedure was completed with another of the same device.No patient complications 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: 21173300
• Report Number: 2124215-2024-83494
• Device Sequence Number: 4276592
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: 08714729838005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/07/2025

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: M0068318250
• Device Catalogue Number: M0068318250
• Device Lot Number: 0034818894
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/07/2025
• Date Device Manufactured: 09/10/2024
• 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: Unknown