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 Problem Insufficient Information (4580)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, implant procedure date, as no event date was reported.Initial reporter name and address: this event was reported to boston scientific corporation legal by the patient's legal representation.The implanting surgeon is (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was implanted during a vaginal sling implant and cystourethroscopy procedures performed on (b)(6) 2016 to treat a patient with cystocele and stress urinary incontinence.The patient was taken to the recovery room in good condition.As reported by the patient's attorney, the patient experienced an unspecified injury.

• 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: 16051486
• MDR Text Key: 306170731
• Report Number: 3005099803-2022-07744
• Device Sequence Number: 1
• Product Code: OTN
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2019
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0000031765
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female