MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO SLIM; INSTRUMENTATION, SURGICAL MESH, TRANSVAGINAL REPAIR OF PELVIC ORGAN PROLAPSE

Model Number	M0068318250
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a transvaginal mesh (tvm) procedure using a capio slim device, after loading the dart into the carrier, the suture was pulled back and tensioned along the capio handle.After the device was fully deployed, the needle broke off from the thread, causing the dart to be detached during securing and the dart remained inside the patient's body.No patient complications reported.
Additional Manufacturer Narrative
Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of dart detachment.
Additional Manufacturer Narrative
Block h11: block b5 updated due to the additional information received on september 24, 2025.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that, during a transvaginal mesh (tvm) procedure using a capio slim device, after loading the dart into the carrier, the suture was pulled back and tensioned along the capio handle.After the device was fully deployed, the needle broke off from the thread on the patient's right side, resulting the dart to be detached during securing and the dart remained inside the patient's body.No patient complications reported.
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 have any visual damage/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 dart detaching could not be confirmed through product analysis.Additionally, the reported patient symptom of unretrieved device fragment is a known risk associated with the use of a capio device and it is noted as such in the device instructions for use.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.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that, during a transvaginal mesh (tvm) procedure using a capio slim device, after loading the dart into the carrier, the suture was pulled back and tensioned along the capio handle.After the device was fully deployed, the needle broke off from the thread on the patient's right side, resulting the dart to be detached during securing and the dart remained inside the patient's body.No patient complications reported.
Additional Manufacturer Narrative
Block h11: correction to blocks d4: lot number and udi and h4: device manufacture date.Upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual inspection of the device did not have any visual damage/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 dart detaching could not be confirmed through product analysis.Additionally, the reported patient symptom of unretrieved device fragment is a known risk associated with the use of a capio device and it is noted as such in the device instructions for use.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.Block h6: device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that, during a transvaginal mesh (tvm) procedure using a capio slim device, after loading the dart into the carrier, the suture was pulled back and tensioned along the capio handle.After the device was fully deployed, the needle broke off from the thread on the patient's right side, resulting the dart to be detached during securing and the dart remained inside the patient's body.No patient complications reported.

• Brand Name: CAPIO SLIM
• Common Device Name: INSTRUMENTATION, SURGICAL MESH, TRANSVAGINAL REPAIR OF PELVIC ORGAN PROLAPSE
• 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 fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23083657
• Report Number: 2124215-2025-65078
• Device Sequence Number: 21266905
• Product Code: PWI
• UDI-Device Identifier: 08714729838005
• UDI-Public: (01)08714729838005
• 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,Followup,Followup
• Report Date (Section B): 01/02/2026

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: 0035706034
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 10/29/2025; 12/09/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/17/2025; 11/24/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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