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

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

Patient Problems Nerve Damage (1979); Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); No Code Available (3191)

Event Date 12/03/2012

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2012 (implant date) as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).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

It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system was implanted into the patient during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, as a result of the implantation, the patient has suffered disfigurement, severe emotional pain, injury, and pain.Subsequently, she underwent additional surgeries to locate and remove mesh, remove portions of the female genitalia, and attempt to repair pelvic organs, tissue, and nerve damage.Additionally, the patient used pain control and other medications, and had injections into various areas of the pelvis, spine, and the vagina.Reportedly, the patient may have to undergo additional surgery in the future and may continue to suffer significant pain, treatment and therapies.Furthermore, it was reported that the patient will continue to sustain severe injuries, serious bodily injury, mental and physical pain, and suffering.

• Brand Name: OBTRYX SYSTEM
• 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 Key: 9674173
• MDR Text Key: 188329547
• Report Number: 3005099803-2020-00198
• Device Sequence Number: 1
• Product Code: OTN
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention