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

Model Number	M0068505110
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	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of dart detachment.
Event or Problem Description
It was reported that during a female mid-urethral sling procedure using an obtryx ii system - halo device, the association was detached from the sling.It was noted that upon opening the device, the association loop was not present.Another obtryx sling was used to successfully complete the procedure.No further patient complications were reported.
Additional Manufacturer Narrative
Correction block b5: there were no patient complications reported.Block h6: imdrf device code a0501 captures the reportable event of dart detachment.Block h11: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual inspection of the returned device did not identify any damage to the delivery devices or the mesh.Visual inspection also revealed both association loops were present; however, one association loop was detached from the dilator leg.Based on the information available and the laboratory analysis the reported allegation of the association loop detaching, was confirmed.It is likely that procedural conditions, such as user handling technique prior to use, resulted in excessive force and/or manipulation on the loop causing it to detach from the dilator leg.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during a female mid-urethral sling procedure using an obtryx ii system - halo device, the association was detached from the sling.It was noted that upon opening the device, the association loop was not present.Another obtryx sling was used to successfully complete the procedure.No patient complications were reported.

• Brand Name: OBTRYX II 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: 19354927
• Report Number: 2124215-2024-30537
• Device Sequence Number: 20758959
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• 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): 06/28/2024

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: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0032639442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2023
• 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