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

Model Number M0068505110

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Calcium Deposits/Calcification (1758); Diarrhea (1811); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Burning Sensation (2146); Chills (2191); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Obstruction/Occlusion (2422); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572)

Event Date 12/20/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was used during an implant procedure performed on (b)(6) 2018.As reported by the patient's attorney, post procedure, the patient experienced pelvic pain, back pain, failed sling, infections and urinary retention issues.The patient also reported suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.Initial reporter name and address:: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

Manufacturer Narrative

Blocks a2 (date of birth) and b7 (other relevant history) have been updated based on the additional information received on april 17, 2023.Correction to section e.Block b3 date of event: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation: (b)(6).Implant surgeon: (b)(6).Block h6: patient code e020201 captures the reportable event of anxiety.Patient code e0206 captures the reportable event of suffering and loss of enjoyment of life.Patient code e1906 captures the reportable event of infections (unspecified).Patient code e2330 captures the reportable event of pain.Patient code e1309 captures the reportable event of urinary retention.Impact code f1202 captures the reportable event of physical impairment, permanent physical injury, and more.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was used during an implant procedure performed on (b)(6) 2018.As reported by the patient's attorney, post procedure, the patient experienced pelvic pain, back pain, failed sling, infections and urinary retention issues.The patient also reported suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.

Manufacturer Narrative

Block h2: additional information: blocks a6 (race), b2 (outcomes attrib to adv event), b5 (event description), d6b (explant date) and h6 (patient codes, impact codes and device codes) has been updated based on the additional information received on june 21, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of december 20, 2018, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).The explanting physician: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable events of e020201 captures the reportable event of anxiety.E0206 captures the reportable event of suffering and loss of enjoyment of life.E1906 captures the reportable event of infections (unspecified).E2330 captures the reportable event of pain.E1309 captures the reportable event of urinary retention.E2311 captures the reportable event of abdominal discomfort and abdominal tenderness.E230901 captures the reportable event of calcifications in the lower pelvis.E2328 captures the reportable event of obstructed urination and 3 mm calculus in the upper pole of the left kidney.E231501 captures the reportable event of pocket of pus.E1715 captures the reportable event of hard-scarred area.E1301 captures the reportable event of dysuria.E0306 captures the reportable event of urosepsis.E1310 captures the reportable event of recurrent uti.E2326 captures the reportable event of mild inflammatory changes around the right kidney and small cyst in the mid-to-lower portion of the right kidney.E020202 - captures the reportable event of depression.The following imdrf impact code capture the reportable event of: f1202 captures the reportable event of physical impairment, permanent physical injury, and more.F12 has been used in the light of this patient had filed a legal claim for an unspecified personal injury related to the device.F1903 captures the reportable event of mesh excision.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was used during an implant procedure performed on (b)(6) 2018.As reported by the patient's attorney, post-procedure, the patient experienced pelvic pain, back pain, failed sling, infections, and urinary retention issues.The patient also reported suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.Additional information received on june 21, 2023.The patient received treatment for stress incontinence on (b)(6) 2018, which involved undergoing an obtryx transobturator sling placement and cystoscopy.These are the findings of the procedure: *the urethra is normal without strictures and scarring.*bladder: normal mucosa, without lesions.*both ureteral orifices were in their normal position and effluxing clear urine.On (b)(6) 2018, the patient reported having a urological procedure the day before.As a result, a foley catheter was inserted, and the patient was sent home with both a straight drain bag and a leg bag.However, the patient experienced difficulty with the leg bag not draining after switching to it.Consequently, the patient visited the emergency department due to abdominal pain and retention.There was a concern regarding the malfunction of the catheter.The nursing staff attempted to replace the catheter but discovered that the patient had connected the bag improperly.Instead of attaching it to the intake valve, it was hooked up to the drainage valve.After securing the foley catheter bag, the patient's symptoms improved, and urine began to flow.She was given oral zofran for her symptoms and the catheter drained smoothly.She was monitored for a while and no additional obstructions were found.The pressure-like sensation in her abdomen also improved.The patient, however, has pain that came from her surgery and incision sites and was treated with percocet.The patient has been discharged for outpatient follow-up and care.She has been advised to come back in case of any new or worsening symptoms.On (b)(6) 2018, the patient presented again to the emergency department due to lower pelvic pain.A foley catheter was in place, however, states that there is some leaking around the catheter.The patient states the pain has been severe and constant since the procedure.On (b)(6) 2020, the patient reported experiencing significant discomfort including incontinence, frequent urination, burning sensation, and urgency.She was unsure whether the tightness of her sling was contributing to her symptoms.Additionally, she had a history of recurrent urinary tract infections.Upon examination, the physician found tenderness in the sling area and suspected that the mesh slings may have migrated toward the bladder neck, causing dysuria and obstructed urination.This could also be a possible cause of her recurrent urinary tract infections, rather than her bladder diverticulum or mild ureteral reflux, as there was no sign of hydronephrosis.In light of the patient's bladder symptoms, the physician recommended the patient have a cystoscopic evaluation of the bladder and urethra to rule out any pathologic conditions affecting the bladder and urethra.The patient has been diagnosed with a bladder diverticulum in the past.Due to her mixed symptoms of urinary incontinence, she will undergo urodynamic evaluation at her next visit.On (b)(6) 2020, the patient had a mesh excision to treat her urinary retention, bladder neck obstruction, and infected mesh sling.Because this was a very thick, hard-scarred area, the mesh sling was immediately identifiable during the procedure.A pocket of pus was discovered as the physician neared the mesh after careful dissection of the paravesical space.The area was copiously irrigated with saline irrigation.The blue color of the mesh was then encountered, and the mesh was carefully dissected.There was an obvious exudate and ongoing infection noted around the mesh sling.At this point, using a right-angle clamp, the mesh was undermined and incised in the midline, with an obvious relaxation of the bladder neck at that time.The mesh was carefully dissected into the area behind the pubic bone.An attempt was made to try to remove as much of the mesh as possible.The dense scar tissue was carefully removed, and the anterior vaginal epithelium was then approximated with a 2-0 vicryl in a running fashion.The urethra was carefully dissected up to 28 times in order to break up some of the scar tissue.A urethrolysis was also performed once the mesh sling was excised by mobilizing the dense scar connective tissue around the posterior aspect of the urethra.Once the posterior urethra was more pliable and mobile, the anterior vaginal epithelium was then reapproximated with 2-0 vicryl in a running fashion.Cystoscopy was performed with bilateral ureteral jet methylene blue spillage, and no injury was noted to the bladder or the urethra.Moreover, the patient was taken to the recovery room in stable condition.On (b)(6) 2020, the patient presents at the emergency room with bilateral flank pain, a history of kidney infection, and urosepsis.The patient also reports having a fever.She reports that she took motrin for her fever and chills, but it didn't help with her lower abdomen discomfort.She also claims to have experienced nausea, vomiting, and diarrhea.During the physical examination of the patient's abdomen, there was tenderness in the suprapubic area.Right, and left costovertebral angle (cva) tenderness was also noted.There is no guarding or rebounding.Murphy's sign, roving's sign, mcburney's sign, the psoas sign, and the obturator sign are all examples of negative indicators.Additionally, the patient underwent a computed tomography (ct) of the abdomen and pelvis without contrast.There is a non-obstructing 3 mm calculus in the upper pole of the left kidney.No other renal calculus has been identified.There are mild inflammatory changes around the right kidney that are relatively similar to the prior study and have uncertain clinical evidence.No definite ureteral calculus has been identified.The courses of the distal ureters are somewhat difficult to identify.The evaluation of solid organs is limited by technique.There is likely a small cyst in the mid-to-lower portion of the right kidney.Evaluation of the other solid organs is also limited.There are coarse calcifications in the liver and spleen that appear similar to those in the previous study and are likely benign.No definite lesion has been identified in the pancreas or adrenal glands.There is no bowel distention.No definite lymphadenopathy or abnormal fluid collection is noted.Moreover, there are numerous surgical clips in the pelvis.There is a cluster of calcifications in the lower pelvis, inferior to the urinary bladder.These are similar to the prior study and of uncertain clinical significance.No definite mass or lymphadenopathy is noted.There may be a trace amount of free fluid in the pelvis.

• Brand Name: OBTRYX II 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15470537
• MDR Text Key: 300440334
• Report Number: 3005099803-2022-05413
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0021244713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Race: White