MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLYFORM SYNTHETIC MESH; MESH, SURGICAL, POLYMERIC

Model Number M0068402400

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Obstruction/Occlusion (2422); Prolapse (2475)

Event Date 11/07/2005

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2005 was chosen as a best estimate based on the date of the mesh was implanted.Initial reporter name and address: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).The explanting physician is: (b)(6).(b)(4).

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report 3005099803-2022-07803 for the associated device.It was reported to boston scientific corporation that an obtryx system - halo and polyform synthetic mesh device was implanted into the patient during an anterior and posterior repair with mesh and transobturator tape sling insertion procedure performed on (b)(6) 2005 for the treatment of cystocele, rectocele and stress urinary incontinence.The patient had experienced pelvic pain, rectocele and bladder neck obstruction.Subsequently, the patient underwent a urethrolysis, transvaginal, secondary, open, including cystourethroscopy, revision of sling for stress incontinence, removal of prosthetic vaginal mesh, and posterior colporrhaphy on (b)(6) 2015.During the procedure, the synthetic mesh was palpable as a wad of material in the anterior vagina and the sling as a tight band over the proximal urethra.The surgeon identified the sling and removed it in sections until the material sank beyond the inferior pubic ramus.The prolapsed mesh was also removed in multiple parts, extending laterally until the pelvic sidewall.They performed a primary repair on the rectocele, which seemed to have a transverse defect of the rectovaginal septum.Furthermore, the cystoscopy revealed no genitourinary tract violations, and the rectal examination at the end was normal.According to reports, the patient tolerated the treatment well and had no issues.

• Brand Name: POLYFORM SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16137264
• MDR Text Key: 307080817
• Report Number: 3005099803-2022-07804
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/11/2023

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: 08/31/2006
• Device Model Number: M0068402400
• Device Catalogue Number: 840-240
• Device Lot Number: R078FH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2005
• 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: 56 YR
• Patient Sex: Female