• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Catalog Number 73200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Fever (1858); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Numbness (2415); Prolapse (2475); Dysuria (2684); Constipation (3274)
Event Date 02/15/2018
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The voluntary user medwatch number is mw5080822.The removed mesh 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
Note: this manufacturer report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and an obtryx halo sling were implanted during a pelvic organ prolapse procedure performed on (b)(6) 2017.According to the complainant, in 2018, she went to see the physician who implanted the device due to severe pain and the stitches that she felt were coming out from her vagina with blood spotting.She also reported to have dyspareunia.The patient gave a urine sample for laboratory and results showed that she has urinary tract infection, bladder infection.She also reported that the physician examined her vagina and told her that some mesh were pushing through on the back of the vaginal wall.Subsequently, the physician put her to sleep and performed an in-office procedure by cutting out the mesh that was eroding from the patient's body.The patient reported that she had the anesthesiologist and nurse aid during this in-office procedure.She was also prescribed with macrobid.She went back to the physician for her scheduled post-operative check-up and the physician is no longer part of her insurance and cost her huge amount of money considering it was not a hospital surgery.Furthermore, she reported that she is still experiencing bladder infection, difficulty to urinate and mesh erosion.She still has severe vaginal/pelvic pain and bleeding, and sexual intercourse was impossible.She stated that she is concerned about all of her vessels, nerves, structures and organs, including her bladder, urethra and bowels.The mesh extrusion, exposure or erosion into her vagina felt like it had invaded her other structures and organs.She has voiding dysfunction and pain during intercourse which has almost destroyed her marriage for 30 years.Neuromuscular problems, acute and chronic pain in her groin, thighs, legs, pelvic abdominal areas and numbness on the legs are also experienced by the patient.Reportedly, her lower back pain was off the chart.She reportedly does not take any pain medication.She has urinary frequency during sleeping hours that never happened before her surgery.She only had the surgery due to urinary retention.In addition, she experienced various allergic reactions like stiffness, swelling, aches in her joints and blisters like nodules developed on her finger joints that lasted for months.The blisters like nodules finally exploded.She believes that it could be an allergic reaction to the mesh.She developed severe constipation, defecation dysfunction that is painful, and her vagina hurts every time she goes to the bathroom.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key8153207
MDR Text Key130025878
Report Number3005099803-2018-61819
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 12/11/2018
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 Catalogue Number73200
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/13/2018
Initial Date FDA Received12/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-