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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 02/23/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a laparoscopic vaginal hysterectomy + enterocele repair + anterior and posterior repair + sling cystourethropexy + cystoscopy + bilateral proximal salpingectomy procedure performed on (b)(6) 2018, for the treatment of menorrhagia, severe dysmenorrhea, pelvic relaxation, cystocele, rectocele, stress urinary incontinence, dyspareunia, and retroflexed uterus.The patient was awakened and returned to the recovery room in good condition.On (b)(6) 2018, the patient came back due to vaginal bleeding.An exam under anesthesia and a suture of the vaginal bleeding site was then performed.Clot was removed from the vaginal vault as she was being prepped.There was a bleeding site on the mucosal edge of the upper pole of the posterior vaginal incision.During the surgery, the bleeding site was identified, and the suture ligated with 1 chromic.The patient was awakened and returned to the recovery room in good condition.

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implant and surgical intervention surgeon is: dr.(b)(6).Assistant: dr.(b)(6).(b)(6) medical center.Block h6: imdrf patient codes e0506 and e0505 capture the reportable events of vaginal bleeding and clot in the vaginal vault.Imdrf impact code f19 capture the reportable event of suture of vaginal bleeding site.

• 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: 17477478
• MDR Text Key: 320569484
• Report Number: 3005099803-2023-04188
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2023

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 Expiration Date: 10/10/2020
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0021244713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female