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

Model Number M0068505000

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

Patient Problems Micturition Urgency (1871); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Chills (2191); Stenosis (2263); Urinary Frequency (2275); Prolapse (2475); Dysuria (2684); Insufficient Information (4580)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, the patient has experienced an unspecified injury.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, the patient has experienced an unspecified injury.**additional information received on january 19, 2022.It was reported that the patient had been diagnosed with stress urinary incontinence, stage 2 cystocele, and rectocele.On (b)(6) 2017, she underwent an anterior and posterior repair, obtryx midurethral sling and cystoscopy.No complications were reported.Medical and surgical history included endometriosis, lash and lysis of fine paraovarian adhesions july 2010, laparoscopic lso and lysis of pelvic adhesions july 2012, type 2 diabetes, and daily cigarette smoking.In (b)(6) 2018, the patient had klebsiella urinary tract infections (utis) which were treated with bactrim.On (b)(6) 2018, her symptoms were worse, and she was switched from bactrim to cipro.Two days later she had not improved and went to the er; renal ultrasound was negative.On (b)(6) she had not improved and report chills, nausea, and constant urethral burning.Her antibiotics were changed to augmentin.Her symptoms did not improve, and the patient was seen (b)(6) 2018 for dysuria, frequency, and flank pain.She was treated with augmentin, but the next day she experienced new onset severe right flank pain and went to the er.She was switched from augmentin to levaquin.On (b)(6) 2018 she reported continuing to have severe bilateral flank pain and periuretheral burning.On (b)(6) 2018, patient went for a follow-up due to persistent urinary tract infection and flank pain for the last six weeks.There was no evidence of mesh erosion or infection on vaginal exam and her cystoscopy was normal.The physician did not believe her symptoms at the time were secondary to her midurethral sling procedure.The assessment included recurrent uti, bladder pain, urethral pain, overactive bladder, and back pain.For the treatment of her bladder pain and overactive bladder, she was started on a trial of oxybutynin and pyridium.She was also given lidocaine gel for urethral pain.The physician did not believe the back pain was related to her prior bladder surgery; it was suspected to be musculoskeletal pain, to be followed up with her primary care physician.On (b)(6) 2018 the patient had a follow-up visit for her recurrent utis, urethral pain, and bladder pain.Her urethral pain was better with the lidocaine gel and her bladder pain had also improved.Her back pain was still present, but not as bad as it had been previously.On (b)(6) 2019, she underwent resection of midurethral sling with cystoscopy for recurrent urinary tract infection after mid-urethral sling.During the procedure, it was noted the sling was appropriately placed and without evidence of infection.The midurethral portion of the mesh was resected without difficulty.Patient was transferred to recovery in stable condition.At a woman's health exam on (b)(6) 2020, the patient reported she has no further utis post sling removal.Exam noted significant scarring in the anterior suburethral area, no palpable sling, and circumferential narrowing at the hymenal ring but more than three finger breadths diameter noted.Assessments included midline cystocele.

Manufacturer Narrative

Correction to: blocks b5 and h6: patient codes.Block b3 date of event: date of event was approximated to (b)(6) 2018 (initial follow-up visit post implant), as no event date was reported.Block e1: this event was reported by the patient's legal representation.The surgeon is: dr.(b)(6).(b)(6) medical center.Block h6: patient codes e2337, e1715, e1715, e2330 and e1310 capture the reportable events of stenosis, scar tissue, dysuria, pain and urinary tract infection.Impact codes f1903 and f2303 capture the reportable events of mesh removal surgery and medication required.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional information received on january 19, 2022 it was reported that the patient had been diagnosed with stress urinary incontinence, stage 2 cystocele and rectocele.On (b)(6) 2017 she underwent an anterior and posterior repair, obtryx midurethral sling and cystoscopy.No complications were reported.In (b)(6) 2018, the patient had klebsiella urinary tract infections (uti's) which were treated with bactrim.On (b)(6) 2018, her symptoms were worse and she was switched from bactrim to cipro.Two days later she had not improved and went to the er; renal ultrasound was negative.On (b)(6), she had not improved and report chills, nausea, and constant urethral burning.Her antibiotics were changed to augmentin.Her symptoms did not improve, and the patient was seen (b)(6) 2018 for dysuria, frequency, and flank pain.She was treated with augmentin, but the next day she experienced new onset severe right flank pain and went to the er.She was switched from augmentin to levaquin.On (b)(6), 2018 she reported continuing to have severe bilateral flank pain and periuretheral burning.On (b)(6) 2018, patient went for a follow-up due to persistent urinary tract infection and flank pain for the last six weeks.There was no evidence of mesh erosion or infection on vaginal exam and her cystoscopy was normal.The physician did not believe her symptoms at the time were secondary to her midurethral sling procedure.For the treatment of her bladder pain, she was started on a trial of oxybutynin and pyridium.She was also given lidocaine gel for urethral pain.The physician did not believe the back pain was related to her prior bladder surgery; it was suspected to be musculoskeletal pain, to be followed up with her primary care physician.On (b)(6) 2018 the patient had a follow-up visit for her recurrent uti's, urethral pain, and ladder pain.Her urethral pain was better with the lidocaine gel and her bladder pain had also improved.Her back pain was still present, but not as bad as it had been previously.On (b)(6) 2019, she underwent resection of midurethral sling with cystoscopy.During the procedure, the midurethral portion of the mesh was resected without difficulty.Patient was transferred to recovery in stable condition.At a woman's health exam on (b)(6), 2020, the patient reported she has no further utis post sling removal.

Manufacturer Narrative

Additional information: blocks a2, b2, b3, b5, b7, h6.Block b3 date of event: date of event was approximated to (b)(6), 2018 (initial follow-up visit post implant), as no event date was reported.Block e1: this event was reported by the patient's legal representation.The surgeon is: dr.(b)(6).(b)(6) medical center.Block h6: patient codes e2330, e1301, e1310 f1903, f2303 capture the reportable event of flank/back/bladder pain, dysuria, urinary tract infection, mesh removal surgery and medication required.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: OBTRYX 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): 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: 11722840
• MDR Text Key: 247249912
• Report Number: 3005099803-2021-01886
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0000050203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Female