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

Model Number M0068504000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Erosion (1750); Fistula (1862); Inflammation (1932); Pain (1994); Perforation (2001); Scar Tissue (2060); Obstruction/Occlusion (2422); Hematuria (2558)

Event Date 08/25/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - curved device was implanted into the patient during a transvaginal dissection and adhesiolysis + partial salpingectomy anterior and posterior colporrhaphy + high uterosacral vaginal vault suspension + transobutrator midurethral sling performed on (b)(6) 2014, for the treatment of pelvic pain, peritoneal traction, or musculoskeletal pain, pelvic organ prolapse with anterior and posterior prolapse and apical prolapse.Findings showed ovaries adhesed to each other and attached to the vaginal cuff up under the bladder base as well.It was an unusual presentation.The patient was awakened and taken to the recovery room in stable condition.On (b)(6) 2022, the patient had revision surgery due to urethrovaginal fistula, erosion of mid urethral sling into the urethra, chronic pelvic pain, right lower quadrant greater than left lower quadrant pain, persistent right ovarian cyst, and pelvic floor tension myalgia.There was through and through erosion of the sling into the urethra making it difficult to pass a foley catheter.Intraoperatively, there was a complete erosion of the sling at 9:00 and 3:00 with a complete perforation.The sling was then dissected.A stone was also identified attached to the sling.The urethrovaginal fistula was identified at the base of the urethra and then granulation tissue was trimmed away.There were dense adhesions in the right ovary to the lateral edge of the rectum were seen and the left ovary was adherent to the sigmoid colon.These adhesions were removed using a ligasure device.Additionally, it was mentioned in a pathology report that the patient had a history of hematuria.The patient tolerated the procedure well without any complications and was taken to the recovery room in stable condition.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2014, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.Block h6: the following imdrf patient codes capture the reportable events of: e2006: erosion; e2314: fistula; e2114: perforation, ureter/urethra; e1715: scar tissue (cicatrix) - granulation tissue; e2330: pain; e2326: inflammation - ovarian cyst; e2101: adhesions; e2328: obstruction - stone attached to the sling; e1302: hematuria.The following imdrf impact codes capture the reportable events of: f1905: device revision or replacement - sling excision; f1901: additional surgery - removal of adhesions and granulation tissue.

• Brand Name: OBTRYX SYSTEM - CURVED
• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17478665
• MDR Text Key: 320568817
• Report Number: 3005099803-2023-04191
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• 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: 08/08/2023

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: 04/30/2017
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: ML00002256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Race: White