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

Model Number M0068502000

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Injury (2348); Dyspareunia (4505); Insufficient Information (4580)

Event Date 05/18/2012

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2012, implant date, as no event date was reported.The lot number (ml00000635) does not match with the reported device in the system search; therefore, the device manufacture and expiration dates cannot be determined.(b)(6).(b)(4).The complaint device 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 advantage fit system device was implanted into the patient during vaginal hysterectomy, vault suspension, anterior repair and mid-urethral sling procedures performed on (b)(6) 2012.As reported by the patient's attorney, after the implantation, the patient had suffered from dypareunia, bleeding from the bladder or vagina, intermittent leaking of fluid from the umbilicus and chronic pelvic pain.The patient took regular panadol for her chronic pelvic pain.Cystoscopy was organized to rule out bleeding from the bladder.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

B3 date of event: date of event was approximated to (b)(6) 2012, implant date, as no event date was reported.E1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).H10: the complaint device 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.H11: blocks d4, g1, g2, h4, h6 and h10 have been corrected.H6: patient code (b)(6) captures the reportable event of pain.Patient code (b)(6) captures the reportable event of dyspareunia.Patient code (b)(6) captures the reportable event of leaking of fluid from the umbilicus.Impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.

Event Description

It was reported that an advantage fit system device was implanted into the patient during vaginal hysterectomy, vault suspension, anterior repair and mid-urethral sling procedures performed on (b)(4) 2012.As reported by the patient's attorney, after the implantation, the patient had suffered from dypareunia, bleeding from the bladder or vagina, intermittent leaking of fluid from the umbilicus and chronic pelvic pain.The patient took regular panadol for her chronic pelvic pain.Cystoscopy was organized to rule out bleeding from the bladder.Boston scientific has been unable to obtain additional information regarding the event to date.The device was not returned for analysis.

• Brand Name: ADVANTAGE 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11175552
• MDR Text Key: 227019337
• Report Number: 3005099803-2021-00079
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00000535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2012
• 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: 31 YR
• Patient Sex: Female