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

Model Number	M0068505000
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	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of dilator detachment of device or device component.
Event or Problem Description
It was reported that an obtryx system - halo device was used during a procedure.During the procedure, it was noted that the tunneling needle lacked solidarization between the plastic sheath of the mesh with the blue end that was equipped with a metallic ring for positioning and for sling traction.The procedure was completed with another of the same device.There were no known patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported that an obtryx system - halo device was used during a procedure.During the procedure, it was noted that the tunneling needle lacked solidarization between the plastic sheath of the mesh with the blue end that was equipped with a metallic ring for positioning and for sling traction.The procedure was completed with another of the same device.There were no known patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of dilator detachment of device or device component.Upon receipt at our quality assurance laboratory, this obtryx system - halo underwent a thorough analysis.Visual inspection of the returned delivery device and mesh assembly found no defects.The analysis of the returned device did not find any issues.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the information available and analysis results, the reported event of dilator detachment of device or device component was not confirmed.A conclusion code of no problem detected was assigned to this investigation.

• Brand Name: OBTRYX SYSTEM - HALO
• 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: 19237543
• Report Number: 2124215-2024-26999
• Device Sequence Number: 18141758
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K040787
• 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): 10/08/2024

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: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0032622551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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