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

Model Number M0068505001

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a transobturator tension free vaginal tape urethral suspension + cystoscopy procedure performed on (b)(6) 2010 due to stress urinary incontinence.During the surgery, there was difficulty advancing the delivery system device on the patient's left side but was successful after three attempts without perforating the vagina.The patient tolerated the procedure well and was brought to the recovery room in satisfactory condition.As reported by the patient's attorney, the patient experienced an unknown injury.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2010, 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: imdrf device code a150205 captures the reportable event of delivery system difficult to advance.Imdrf patient code e2401 captures the reportable event of unspecified injury.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a transobturator tension free vaginal tape urethral suspension + cystoscopy procedure performed on (b)(6) 2010 due to stress urinary incontinence.During the surgery, there was difficulty advancing the delivery system device on the patient's left side but was successful after three attempts without perforating the vagina.The patient tolerated the procedure well and was brought to the recovery room in satisfactory condition.As reported by the patient's attorney, the patient experienced an unknown injury.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to october 19, 2010, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: imdrf device code a150205 captures the reportable event of delivery system difficult to advance.Imdrf patient code e2401 captures the reportable event of unspecified injury.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.

• 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: 17125056
• MDR Text Key: 317132014
• Report Number: 3005099803-2023-03095
• 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,Followup
• Report Date: 06/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: M0068505001
• Device Catalogue Number: 850-500
• Device Lot Number: 1ML0030205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female