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

Model Number M0068505110

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The reported healthcare facility is: (b)(6).Imdrf impact code f23 captures the reportable event of retrieving the piece of sleeve/mesh from the patient through extending the groin incision and using kelly forceps.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was used during a mid urethral sling procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.During the procedure, the physician tried to cut the mesh away from the plastic sleeve, but instead of cutting the blue string, he cut the sleeve and the mesh.The mesh fell off into the patient and was then tried to remove by extending the groin incision and using kelly forceps to grab the piece from underneath the skin; however, the mesh remained underneath the dermis as the physician struggled to retrieve it.They were able to successfully retrieve the mesh.The physician reported that this is a user error.The procedure was completed with another obtryx ii system - halo device.There were no patient complications reported as a result of this event.Note: it was reported that the sleeve was cut upon removal of the plastic sleeve from the mesh; however, the instructions for use states, "once proper tension is achieved, cut the leader loop that is on the outside of the sleeve that is connecting the dilator leg and sleeve to the mesh.Pull outward on the dilator to remove the sleeve leaving the mesh in place.".

• Brand Name: OBTRYX II SYSTEM - HALO
• Type of Device: 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16717905
• MDR Text Key: 313071871
• Report Number: 3005099803-2023-01757
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: White