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); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact date is unknown, event occurred in august 2024.Block h6: device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that the patient underwent a retropubic mid-urethral sling procedure.During the same surgery, sacrospinous hysteropexy, anterior colporrhaphy, and posterior colporrhaphy procedures were also performed.It was noted that the bullet broke off the suture and got stuck into the metal inside the device.
Additional Manufacturer Narrative
Blocks b5, e1 (initial reporter title), e1 (initial reporter first name), e1 (initial reporter last name), e1 (initial reporter email), e3, h2, h6 (device codes), and h11 have been updated based on the additional information received on 22oct2024.Block b3: the exact date is unknown, event occurred in august 2024.
Event or Problem Description
It was reported that the patient underwent a retropubic mid-urethral sling procedure.During the same surgery, sacrospinous hyesteropexy, anterior colporrhaphy, and posterior colporrhaphy procedures were also performed.It was noted that the bullet broke off the suture and got stuck into the metal inside the device.----additional information received on october 22, 2024.It was later clarified that the bullet did not break off the suture.During the procedure, the suture was not catching the ligament, and the dart was not caught in the cage.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

• 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: 20419082
• Report Number: 2124215-2024-62844
• Device Sequence Number: 20888531
• Product Code: FHQ
• UDI-Device Identifier: 08714729753070
• UDI-Public: 08714729753070
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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 Expiration Date: 06/14/2026
• Device Model Number: M0068311250
• Device Catalogue Number: 76250
• Device Lot Number: 0031828631
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/12/2024
• Date Device Manufactured: 06/15/2023
• 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
• Patient Weight: 106 KG
• Patient Race: White