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 Erosion (1750); Calcium Deposits/Calcification (1758); Diarrhea (1811); Fatigue (1849); Flatus (1865); Inflammation (1932); Nausea (1970); Perforation (2001); Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684); Fluid Discharge (2686); Constipation (3274); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(6) medical center (b)(6).(b)(6).(b)(4).

Event Description

Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report # 3005099803-2022-05662 for the associated device information.It was reported to boston scientific corporation that an obtryx system - halo was used during a cystoscopy with a tension-free vaginal obturator tape mid urethral sling procedure performed on (b)(6) 2011 to treat a patient with stress urinary incontinence, urinary urgency and hypermobility of the urethra.After piercing the obturator membrane with the obtryx halo, it was noted that the vagina had been pierced laterally.The physician backed the trocar out of the area and reestablished the plane anterior, after which the procedure continued without complications.On (b)(6) 2021, the patient experienced a slimy discharge and gas with bowel movement.No abdominal pain, fever, nausea nor vomiting were noted.The patient just noted mucus and she tends to be constipated.The patient was going to the urologist as she was having urinary tract infections (utis) and she had an imaging which revealed a sling bladder tack was growing into her urethra, so she was going to have a surgery to have this corrected.The patient also presented with complaints of diarrhea.The patient's diarrhea has been occurring in an intermittent pattern for three days.The course has been constant.The stools were watery and mixed with mucus.The volume of the stools was small.The symptoms have been associated with nausea.On (b)(6) 2021, the patient presented with recurrent urinary tract infection (uti), frequent dysuria (recurrent) and urethral calculus.The patient underwent cystoscopy with removal of urethral calculus and removal or revision of sling for stress incontinence procedures.Upon cystoscopy, it was revealed that the patient had a stone located in the mid urethra.It appeared that there might be some mesh material associated with this.During the procedure, after achieving adequate general laryngeal mask airway (lma) anesthesia, the patient was sterilely prepped and draped in the dorsal lithotomy position.Attention was turned to the meatus which appeared to be adequate for the procedure and using the 22-french cystoscope sheath pan cystoscopy was performed.The urethra appeared to be of normal caliber up to the bladder neck.There was a stone noted in the mid to distal urethra and a piece of mesh could be seen on the edge of this.The bladder was smooth without lesions.The ureter orifice ease were orthotopic.The bladder wall was smooth and there was no diverticular cellule formation.The catheter was removed and replaced with an 18 french foley.The foley was placed to gravity drainage.The anterior vaginal wall was looked, and anesthetized with about 6 cc of 1% xylocaine with epinephrine.A vertical incision was created approximately 1.5 cm from the external meatus on the anterior vaginal wall going towards the bladder neck.The incision was about 2 cm long.The mesh could be palpated laterally on the left side and the physician was able to use a right angle clamp to snare the mesh and pulled this down.The physician then transected the mesh freeing it from the attachments laterally and then retracting it medially.At this point, urine began to leak from the urethra.The physician tried to dissect the urethral wall from the mesh; however, it was incorporated into this portion of the mesh so the physician transected the edge of the urethra at the mesh proximally and then distally.The physician dissected to the patient's right side and mobilized the mesh from the urethra in this area and then transected the section removed.The physician then placed a #4-0 vicryl suture in the edge of the urethra proximally and closed the defect.The area was inspected using a cystoscope and the physician realized that the lateral edge of the closure had not been gotten into and then used a #4-0 vicryl to close this.The physician re-inspected the area using a 22-french cystoscope and the area appeared to be nicely approximated and there was no evidence of any gap in the epithelium of the urethra.With the urethra reapproximated, the physician then closed the vaginal epithelium with interrupted #3-0 chromic suture in a horizontal mattress fashion.The physician then placed vaginal packing with premarin cream into the vaginal opening and pressure was placed against the urethra with the 18-french foley.Foley was placed to gravity drainage.The patient was then awakened from anesthesia and was transferred to the recovery room in stable condition.Upon pathologic analysis of the specimen provided from the procedure, it revealed that the specimen was reactive to urothelium with von brunn nest, cystitis glandularis and muscularis mucosa were present.On (b)(6) 2021, the patient experienced stress urinary incontinence.The patient underwent a sling operation for stress incontinence with planned placement of lynx system device.The patient was anxious to have the sling excised about three months ago replaced because of severe stress incontinence she has been experiencing since the sling was excised.During the procedure, after achieving general laryngeal mask airway (lma) anesthesia, the patient was sterilely prepped and draped in the dorsal lithotomy position.Attention was turned to the introitus where an 18-french foley catheter was placed and the anterior vaginal wall was injected with 1% xylocaine with epinephrine a total of 10 cc in an effort to achieve reduced blood flow to separate the tissues.The bladder was then examined with the cystoscope after removing the foley and the area where the urethral surgery had been performed was intact with a slight left lateral pocket.The foley was then returned and an incision in the anterior vaginal wall proxy 1 cm proximal to the urethra was started.The physician selected an island of epithelium that the physician excised the epithelial surface from and maintained the fascial tissue overlying the urethra.The physician then made a pocket to either side extending the incision cephalad and separated the urethra on the right and left sides.The physician then placed the sling trocar on the left side from an anterior incision using the physician's finger to guide the trocar into the vaginal incision.The physician's finger was to the left of the urethra between the trocar and the urethra.The physician then placed the sling onto this trocar and pulled it back into the wound.There was copious bleeding from the incision site on the anterior abdominal wall.Pressure was applied as the physician then positioned the right trocar.The physician then pulled the sling up into the abdominal wall area again.The physician then removed the foley and inserted the cystoscope again to inspect the bladder walls and the anterior bladder neck tissue making sure that the sling did not encroach on the bladder.The physician noted that there was leakage of irrigant into the wound which the physician thought was coming around the cystoscope; however, on carful inspection, it was coming from the urethral area.The physician then removed the cystoscope to the urethra and found that the edge of the envelope surrounding the sling was actually encroaching inside the urethral lumen in the area of the pocket that the physician saw on the original cystoscopy.Given the separation between the trocar and the urethra when the physician placed it, the physician believed that the tissue must have been too delicate and as the physician pulled the sling through, it must have torn the urethra.Unfortunately, as a result of this, the physician did not feel that they should leave the foreign material in the area and the physician completely removed the sling material.The physician placed 2 sutures in the periurethral tissue to pull the defect together using #4-0 chromic.The physician then placed the foley catheter and closed the vaginal epithelium with #3-0 chromic suture.The physician removed the 1 cm tissue that was left over the urethra.The physician completely excised this and then closed the vaginal incision.The physician then packed the vagina with 4 inch kerlix impregnated with premarin cream.The patient was then awakened from anesthesia and transferred to the recovery room in stable condition.On (b)(6) 2021, the patient was seen for a planned preoperative visit for a non-bsc suprapubic mid urethral sling.The patient was experiencing significant urinary incontinence leaking urine with position change, sneezing, coughing, laughing, and this had put her out of work as she was near constantly wet.Upon examination, the patient reported fatigue and difficulty urinating.Genitourinary examination revealed that the genitalia was mildly atrophic with no significant cystocele or rectocele.Urethrovesical junction hypermobility was definite with cough and incontinence was significant upon lithotomy position.Normal cuff was nonpalpable adnexa.The assessment was mixed incontinence.On (b)(6) 2021, the patient underwent a kelly plication suprapubic mid urethral sling cystourethroscopy procedure to treat her stress urinary incontinence using a non-bsc sling.

• 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: 15551962
• MDR Text Key: 301271494
• Report Number: 3005099803-2022-05661
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: ML00000241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female