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

Model Number M0068502111

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

Patient Problems Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987)

Event Date 02/24/2011

Event Type  Injury  

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implant surgeons are: (b)(6).Block h6: imdrf patient codes e211401 and e0506 capture the reportable events of bladder perforation and bleeding from the right tube.Imdrf impact code f23 capture the reportable event of right salpingectomy due to bleeding.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a total vaginal hysterectomy + anterior repair + (tension-free vaginal tape) tvt sling + cystoscopy procedure performed on (b)(6) 2011, for the treatment of uterine prolapse, cystocele, stress urinary incontinence.Findings included uterine prolapse to halfway vagina and cystocele at the hymenal ring.Uterus size 6-11 weeks.Tubes and ovaries were normal.No lesions.Cystoscopy showed no problems, but there was a small perforation on the left posterolateral wall and minimal bleeding.Indigo carmine seen from both ureteral orifices.During the procedure, there was some bleeding from the right tube, and was decided to perform a right salpingectomy.The ovary noted to be normal and hemostatic after the right fallopian tube was ligated.While the tvt sheets were in place, cystoscopy was performed noting no damage to the bladder, no tvt sheets noted within the bladder.However, one area of the bladder at the lateral aspect noted a small perforation, possibly secondary to the cystoscope.The bleeding was controlled.Also, indigo carmine given and excellent flow from both ureters visualized with the cystoscopy.The patient was taken to the recovery room in stable condition.

• Brand Name: ADVANTAGE FIT 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18039387
• MDR Text Key: 326971348
• Report Number: 3005099803-2023-05825
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729784777
• UDI-Public: 08714729784777
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• 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: 10/31/2023

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: 09/30/2013
• Device Model Number: M0068502111
• Device Catalogue Number: 850-211
• Device Lot Number: 1ML0091603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female