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

Model Number	M0068504110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	12/11/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an obtryx ii system - curved device was implanted into the patient during an anterior vaginal wall repair, transobturator mid-urethral sling placement and cystoscopy procedure performed on (b)(6) 2015 for the treatment of stress urinary incontinence, midline cystocele and hypermobility of urethra.The procedures' findings are as follows: cystocele of the midline, grade 3.The bladder mucosa and urethra were found to be normal appearing, with no indication of damage.The patient was woken and brought to the recovery room in a stable and satisfactory postoperative condition.According to reports, the patient had pelvic pain and a small pelvic hematoma.On (b)(6) 2016, the patient underwent a mid-urethral sling revision, evacuation of a small pelvic hematoma, and cystoscopy.During the procedure, a vertical incision was made through the full thickness of the vaginal wall between the two allis clamps.The vaginal mucosa was separated from the underlying fascia using metzenbaum scissors.The periurethral spaces were then dissected further with metzenbaum scissors.The right periurethral area was filled with old blood.Then, thorough irrigation was carried out using the antibiotic solution of bacitracin.After the clot was evacuated, a thick fibrous band was palpated.The right periurethral tunnel was involved, and the metzenbaum scissors were used to lyse it.At this point, it was observed that the sling mesh had been thoroughly embedded in the tissue.After that, a cystoscopy was done, which showed normal-appearing bladder mucosa, bilateral ureteral orifices, and normal urethral findings.No signs of mesh erosion were found.A foley catheter was then reinserted and attached to gravity drainage after the cystoscope was withdrawn.There was still some continued bleeding involving the right periurethral space, and surgicel as a coagulant was then inserted into this area.The vaginal mucosa was slightly trimmed.The vaginal mucosa was then reapproximated using 2-0 vicryl suture with interrupted sutures placed.Hemostasis was visualized.A vaginal pack was then inserted as a pressure dressing.This completed the procedure.The patient was awakened and transferred to the recovery room in stable and satisfactory postoperative condition.
Additional Manufacturer Narrative
Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2015, was chosen as a best estimate based on the date of mesh was implanted.This event was reported by the patient's legal representation.The implanting and revising physician is: (b)(6).(b)(4).

• Brand Name: OBTRYX II SYSTEM - CURVED
• 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): 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: 16094492
• Report Number: 3005099803-2022-07634
• Device Sequence Number: 6651619
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: 08714729839255
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2018
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: ML00003035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female