MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; 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	Pain (1994); Obstruction/Occlusion (2422); Hematuria (2558); Dysuria (2684); Insufficient Information (4580)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2017 as no event date was reported.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that the patient was diagnosed with pelvic pain, dysmenorrhea, dyspareunia and stress urinary incontinence.On (b)(6) 2017, the patient was implanted with an obtryx transobturator mid-urethral sling system during a total robotic hysterectomy, bilateral salpingectomy and an obtryx ii transobturator sling procedure.The patient went for an outpatient visit to the hospital on (b)(6) 2017.According the patient, she had experienced 3 days of intermittent flank pain with nausea and vomiting.Reportedly, the patient underwent a computed tomography scan procedure and a 3mm proximal left ureteral stone with obstruction was noted.Subsequently, the patient was advised to undergo a cystoscopy, left retrograde and left ureteral stent placement on (b)(6) 2017, the patient went for an outpatient visit with an admitting diagnosis of calculus of ureter.During the flat plate abdomen x-ray, a minimal right nephrolithiasis and numerous phleboliths overlying the pelvis was noted.On (b)(6) 2018, the patient went for an outpatient visit with multiple chief complaints.The patient reports that she had experienced a pain on her abdomen with nausea and vomiting.She also noticed that her stool was dark, tarry and very foul-smelling.The patient also had a subjective fever and chills.Reportedly, the patient was prescribed with medications to be used as needed for further symptomatic relief at home.Lastly, on (b)(6) 2019, the patient had experienced a difficulty in urinating, flank pain and hematuria.The patient stated that the pain is sharp and stabbing has been intermittent.She also stated that the pain is associated with some nausea and vomiting.Reportedly, a small non-obstructing calculus were seen in both kidneys and there were small pelvic calcified phleboliths around the ureterovesical junction (uvj) bilaterally and in vaginal cuff region.Reportedly, the patient was prescribed with medications to be used to treat the adverse effects.

• Brand Name: OBTRYX SYSTEM
• 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
• MDR Report Key: 12376615
• Report Number: 3005099803-2021-04408
• Device Sequence Number: 11747039
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: 08714729839255
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: 09/19/2019
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: 0000043161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR