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

Model Number M0068505110

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Dysuria (2684); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 04/12/2016

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the date of the sling was implanted.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The excised mesh 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 Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted into the patient during an anterior repair, transobturator tape (tot) sling, and cystoscopy procedure performed on (b)(6) 2016 to treat stress urinary incontinence and cystocele.On (b)(6) 2016, during the post-operative follow-up visit, the patient mentioned that she had vaginal discharge developed 2 weeks ago.After the procedure, the patient experienced dyspareunia, chronic pelvic pain, mesh related pain secondary to genitourinary mesh graft, transobturator sling, and urinary retention.On examination and assessment in the clinic, the patient was noted to have a transobturator sling with a partially exposed left arm which was tight at palpation which replicated the patient's pain symptoms.Symptoms were very negatively impacting her quality of life.The patient was counseled on management options, and after counseling, she elected to proceed with excisional surgery.On (b)(6) 2020, the patient mentioned during assessment that she had urinary frequency, vaginal dryness, painful urination, urinary urgency, excessive urination at night, painful intercourse, and urine leakage.Subsequently, the patient underwent the sling removal, adjacent tissue transfer-vaginal, and cystourethroscopy procedure.During the procedure, it was observed that there was mesh exposure at the anterior vaginal wall consistent with the transobturator sling, and it was excised.Reportedly, the patient tolerated the procedure well.

• 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): 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: 12373074
• MDR Text Key: 268321050
• Report Number: 3005099803-2021-04314
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: ML00003538
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 54