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

Model Number M0068505111

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

Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994); Chills (2191); Injury (2348); Weight Changes (2607)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.

Event Description

As reported by the patient's attorney, an obtryx ii system sling was implanted during a rectocele repair procedure performed on (b)(6) 2014.On (b)(6) 2016, the patient underwent a surgery to revise the obtryx ii mid-urethral sling.During the procedure, the physician made the following findings: "appearance the sling noted there along the upper mid urethra, central portion of the sling was excised using metzenbaum scissors, an approximately 1 cm margin lateral on either side of the midline, the central portion of the urethra was felt more mobile and free, though there was still some scar tissue noted anteriorly.The vagina was irrigated and cleared of all clots and debris.Cystoscopy was performed with no evidence of injury to the urethra or bladder." on (b)(6) 2017, the patient underwent a surgery to revise and excise the obtryx ii mid-urethral sling.During the procedure, the physician made the following findings: "band of sling material on right side of upper vagina and detention, that appears to be the focal point of the patient's pain, this area of the sling was excised." according to the complainant, the patient experienced severe pain, nausea, diarrhea, chills, loss of appetite, and impairment of her urinary tract, which have impaired her activities of daily living.The patient continues to experience complications related to the obtryx ii mid-urethral sling and has required additional surgeries to repair the damage.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: OBTRYX II 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: 7845573
• MDR Text Key: 119207076
• Report Number: 3005099803-2018-60164
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729839279
• UDI-Public: 08714729839279
• 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: Physician
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: M0068505111
• Device Catalogue Number: 73208
• Device Lot Number: ML00002581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• 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