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

Model Number M0068505001

Device Problem Material Integrity Problem (2978)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Abnormal Vaginal Discharge (2123); Urinary Incontinence (4572)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2016, the date of mesh removal surgery, as no event date was reported.Block e1: this event was reported by the patient's legal representation.Implant surgeon: dr.(b)(6).Assistant: dr.(b)(6).(b)(6).Mesh removal surgeon: dr.(b)(6).Assistant: dr.(b)(6).Block h6: imdrf patient codes e2006, e1304 and e1401 capture the reportable events of vaginal mesh erosion, overactive bladder and vaginal discharge.Imdrf impact code f1905 capture the reportable event of mesh removal surgery.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a transobturator tape subvesical sling + diganostic cystoscopy procedure performed on (b)(6) 2008 for the treatment of stress urinary incontinence.Findings showed patient had a healed vaginal cuff from previous hysterectomy and small cystocele.The patient tolerated the procedure well and taken to recovery in good condition.Postoperatively, on (b)(6) 2016, the patient had to undergo removal of mesh sling, botox injection, bladder with cystoscopy due to overactive bladder, mixed urinary incontinence and vaginal mesh erosion.Patient presented with intermittent bleeding and discharge and was found to have a vaginal mesh exposure.On examination under anesthesia, she had foul smelling mesh.There was no purulent material to culture in this area, only friable tissue.The mesh was not intact, which was consistent with preoperative evaluation.On her right, the mesh was retracted deep to the ischiopubic ramus.On the left, the mesh end was found to be in the midline at rest.These were both removed to the lateral most point possible.At the end of the case, all botox injection sites were hemostatic and there was no defect to the bladder or urethra.

• Brand Name: OBTRYX SYSTEM
• 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: 16761052
• MDR Text Key: 313502305
• Report Number: 3005099803-2023-01876
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: 08714729718994
• 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: 04/18/2023

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: 12/31/2009
• Device Model Number: M0068505001
• Device Catalogue Number: 850-500
• Device Lot Number: 0ML6121504
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female