MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number	M0068311250
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of dart detachment of device or device component.
Event or Problem Description
It was reported that during a sacrospinous ligament fixation procedure using two capio devices, it would not capture the suture and the heads broke off the suture line.There was no information on what completed the procedure.There were no patient complications reported.Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 2124215-2024-38799 for the first capio device, and 2124215-2024-38800 for the second capio device.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of dart detachment of device or device component.Block h11: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual analysis identified that the catch was deformed.A functional test was not performed due to the condition of the device.Based on the information available and analysis results, the procedure includes 2 visual inspections of the component during the manufacturing process, and a functional actuation test that verifies the catch captures the suture correctly.There is no reason to conclude that the cause of the defect is related to the manufacturing process.A conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during a sacrospinous ligament fixation procedure using two capio devices, it would not capture the suture and the heads broke off the suture line.There was no information on what completed the procedure.There were no patient complications reported.Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 2124215-2024-38799 for the first capio device, and 2124215-2024-38800 for the second capio device.

• Brand Name: CAPIO
• Common Device Name: HOLDER, NEEDLE, GASTROENTEROLOGIC
• 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: 19669241
• Report Number: 2124215-2024-38799
• Device Sequence Number: 14255942
• Product Code: FHQ
• UDI-Device Identifier: 08714729753070
• UDI-Public: 08714729753070
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 10/11/2024

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: M0068311250
• Device Catalogue Number: 76250
• Device Lot Number: 0033808936
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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: Unknown