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

Model Number M0068505000

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

Patient Problems Pain (1994); Prolapse (2475); Constipation (3274); Urinary Incontinence (4572)

Event Date 06/23/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was implanted during an anterior colporrhaphy and placement of transobturator sling procedures performed on (b)(6) 2009 to treat a patient with second degree cystocele with some redundant vaginal mucosa just under the periureteral area, and persistent stress urinary incontinence.There were no complications at the conclusion of the procedure.On (b)(6) 2010, the patient was seen and examined who primarily presented with recurrent stress urinary incontinence status post two suburethral slings and an anterior colporrhaphy.She also has a symptomatic rectocele with splinting for defecation and uterine prolapse with associated pain.Preoperative diagnosis includes symptomatic, recurrent pelvic organ prolapse encompassing stage two cystocele, stage three rectocele, stage one uterine prolapse and stress urinary incontinence.The patient underwent an anterior colporrhaphy with a non-boston scientific mesh augmentation, anterior bilateral colpopexy, cystoscopy, posterior colporrhaphy with bilateral sacrospinous ligament, posterior colpopexy procedures.The previously placed mesh slings were clearly identified in the patient's right.The slings were then isolated with blunt and sharp dissection.They were transected using a 15 blade and then removed from the field relieving the tension and resulting in full mobility of the anterior vaginal wall.The remainder of the procedures were performed.The patient was transferred to the recovery room in stable condition.No operative complications were noted.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2010, revision procedure date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

• Brand Name: OBTRYX SYSTEM - HALO
• 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: 15645615
• MDR Text Key: 302160039
• Report Number: 3005099803-2022-05947
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0ML9010702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female