MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068503000
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	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that a lynx system was used during a tension-free vaginal tape (tvt) procedure performed on (b)(6) 2023.During the procedure, after the tape was attached to the introducers, while pulling the introducer needles up through the abdominal incisions, the tape detached on both sides before it cleared the abdominal skin.There was no way to reach the detached end which necessitated repeating the entire process of placing the tape.A photo of the device outside the patient was provided, showing both the delivery devices and the mesh within the protective sleeves.The blue dilators were still attached to the introducers, but both of the dilators were completely detached from the clear plastic sleeves.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code: a0501 captures the reportable event of the detachment of the dilator.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of the detachment of the dilator.Block h10: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual inspection of the device showed that the dilators were separated from the mesh assembly and attached to the needle slots on the delivery devices.The mesh appeared in good condition and centering tab was still attached to the mesh assembly; however, the mesh assembly sleeve ends appeared to be cut.Based on the information available and analysis results, the mesh assembly sleeve appeared to have been cut at the area where the dilators should have been.It is likely that during the procedure the customer went to cut the sleeve during the placement of the mesh in turn causing issues when pulling the mesh through the abdominal wall.A conclusion code of unintended use error caused or contributed to event was assigned to this investigation, which indicates that the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.
Event or Problem Description
It was reported to boston scientific that a lynx system was used during a tension-free vaginal tape (tvt) procedure performed on (b)(6) 2023.During the procedure, after the tape was attached to the introducers, while pulling the introducer needles up through the abdominal incisions, the tape detached on both sides before it cleared the abdominal skin.There was no way to reach the detached end which necessitated repeating the entire process of placing the tape.A photo of the device outside the patient was provided, showing both the delivery devices and the mesh within the protective sleeves.The blue dilators were still attached to the introducers, but both of the dilators were completely detached from the clear plastic sleeves.No further information has been obtained despite good faith efforts.

• Brand Name: LYNX SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18579553
• Report Number: 2124215-2024-03060
• Device Sequence Number: 8246501
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 12/12/2024
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0028545815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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