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

Model Number M0068505110

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/10/2013

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2013, implant procedure date, as no event date was reported.This event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).(b)(4).

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report for the associated device.It was reported to boston scientific corporation that an obtryx ii system - halo and uphold lite vaginal support system device was implanted into the patient during a sacrospinous colposuspension with uphold lite and obtryx transobturator mid-urethral sling placement procedure performed on (b)(6) 2013 for the treatment of progressive pelvic organ prolapse (grade 3 cystocele), overactive bladder symptoms and stress incontinence.During the procedure, it was noted that there was some inflammatory reaction surrounding the urethra.It was reported that the patient tolerated the procedures well with no complications.

• Brand Name: OBTRYX II 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: 15979959
• MDR Text Key: 305489450
• Report Number: 3005099803-2022-07324
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729839279
• UDI-Public: 08714729837565
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2022

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: 03/31/2015
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: ML00001372
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2013
• 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): Other
• Patient Age: 52 YR
• Patient Sex: Female