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

Model Number M0068504110

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

Patient Problems Erosion (1750); Chest Pain (1776); Pain (1994); Discomfort (2330); Dyspareunia (4505)

Event Date 01/12/2016

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was used during an excision of vaginal transobturator tape (tot) sling mesh, and transurethral cystoscopy procedure performed on (b)(6) 2016, for the treatment of symptomatic pelvic organ prolapse and sensing a bulge with activity.During the procedure a cystoscopy was performed confirming both ureters functioned appropriately; there were no lesions or stones noted within the bladder or urethra.There were no patient complications reported.On (b)(6) 2022, the patient noted a sandpaper sensation intermittently, as well as hispareunia, increased discomfort, and a rough edge felt with palpation.A cystoscopy was performed to evaluate the urethra and bladder; however, there were no signs of mesh or lesions.Additionally, a vaginal exam did not identify erosion symptoms or abnormalities to the vaginal mucosa either.The sling was palpated in the normal position with no undue tension.A surgical procedure was then performed to excise the vaginal tot sling mesh.A 4-cm inverted u-shaped skin incision was made across an eroded portion of the mesh.The vaginal mesh was removed using traction and counter traction until it was released from the obturator membrane; however, it was noted that the mesh segments in the obturator membrane on the right and left sides remained in situ.A transurethral cystoscopy was done and confirmed both ureters functioning, effluxing, and an intact bladder and urethra.The patient was returned to the recovery room in stable condition.Two hours after the procedure, the patient noted chest pain the middle of the chest and gas pain; however, no additional orders were provided.

Manufacturer Narrative

Lock b3: the exact event onset date is unknown.The provided event date of january 12, 2016, was chosen as the best estimate based on the revision date.Block h6: imdrf patient code e2006 captures the reportable event of erosion.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e233001 captures the reportable event of chest pain.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf impact code f2203 captures the reportable event of the cystoscopy procedure.Imdrf impact code f1905 captures the reportable event of mesh removal.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was used during a trans obturator tape placement, sacrospinous ligament fixation, anterior and posterior repairs, perineorrhaphy, and transurethral cystoscopy procedure performed on (b)(6) 2016, for the treatment of symptomatic pelvic organ prolapse and sensing a bulge with activity.During the procedure a cystoscopy was performed confirming both ureters functioned appropriately; there were no lesions or stones noted within the bladder or urethra.There were no patient complications reported.On (b)(6) 2022, the patient noted a sandpaper sensation intermittently, as well as hispareunia, increased discomfort and a rough edge felt with palpation.A cystoscopy was performed to evaluate the urethra and bladder; however, there were no signs of mesh or lesions.Additionally, a vaginal exam did not identify erosion symptoms or abnormalities to the vaginal mucosa either.The sling was palpated in the normal position with no undue tension.A surgical procedure was then performed to excise the vaginal tot sling mesh.A 4-cm inverted u-shaped skin incision was made across and eroded portion of the mesh.The vaginal mesh was removed using traction and counter traction until it released from the obturator membrane; however, it was noted that the mesh segments in the obturator membrane on the right and left sides remained in situ.Transurethral cystoscopy was done and confirmed both ureters functioning, effluxing, and an intact bladder and urethra.The patient was returned to the recovery room in stable condition.Two hours after the procedure, the patient noted chest pain the middle of the chest and gas pain; however, no additional orders were provided.

Manufacturer Narrative

Correction to blocks b5 and h10.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2016, was chosen as the best estimate based on the revision date.Block h6: imdrf patient code e2006 captures the reportable event of erosion.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e233001 captures the reportable event of chest pain.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf impact code f2203 captures the reportable event of the cystoscopy procedure.Imdrf impact code f1905 captures the reportable event of mesh removal.

• Brand Name: OBTRYX II SYSTEM - CURVED
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19019801
• MDR Text Key: 339113209
• Report Number: 2124215-2024-18211
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: 08714729839255
• 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
• Report Date: 05/14/2024

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: 08/18/2018
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: ML00003140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female