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

Model Number M0068505001

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

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 05/30/2013

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2013 was chosen as a best estimate based on the date of mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) health system.(b)(6).Explant surgeon: dr.(b)(6).Facility: hospital (b)(6).Block h6: imdrf patient codes e2006 and e2114 capture the reportable events of bladder mesh erosion and small puncture in the bladder.Imdrf impact code f1905 and f23 capture the reportable events of mesh removal surgery and small puncture closed with interrupted 3-0 chromic suture.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a pubovaginal sling + cystocele repair with mesh procedure performed on (b)(6) 2011 for the treatment of cystocele and stress incontinence.During the procedure, it was noted that a small puncture was made in the bladder while passing through the endopelvic fascia.This was closed with interrupted 3-0 chromic suture.It was noted that one of the small stab incisions in the obturator foramen was bleeding at the end.A small stitch was placed and the bleeding stopped.The patient tolerated the procedure well.There was minimal blood loss through the procedure, and she was extubated and transferred to the recovery room without any problems.On (b)(6) 2013, the patient underwent mesh removal surgery due to bladder mesh erosion.This report was originally submitted via asr.- report identification number: (b)(4).- submission period: july 2, 2014 to august 31, 2014.- asr exemption number: e2013036.- pro code: otn.

• 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): 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: 16996949
• MDR Text Key: 315883102
• Report Number: 3005099803-2023-02758
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: 08714729718994
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2023

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: 01/31/2014
• Device Model Number: M0068505001
• Device Catalogue Number: 850-500
• Device Lot Number: 1ML1010606
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female