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 Injury (2348); Insufficient Information (4580)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, implant 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).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was implanted into the patient during vaginal hysterectomy + anterior and posterior repair + transobturator suburethral sling with cystoscopy procedures performed on (b)(6) 2016 to treat uterine prolapse and moderate cystocoele and rectocoele.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported that an obtryx system - halo was implanted into the patient during vaginal hysterectomy + anterior and posterior repair + transobturator suburethral sling with cystoscopy procedures performed on (b)(6) 2016 for the treatment of prolapse and urodynamic stress incontinence.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.

Manufacturer Narrative

Update: block h6: impact code and conclusion code.Block b3 date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of the patient had filed a legal claim for an unspecified personal injury related to the device.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 11164733
• MDR Text Key: 226641600
• Report Number: 3005099803-2021-00029
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2019
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: ML00003511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female