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

Model Number M0068503000

Device Problem Positioning Problem (3009)

Patient Problem Internal Organ Perforation (1987)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.(b)(6).Imdrf patient code e211401 captures the reportable event of small bladder puncture.

Event Description

Note: this manufacturer report pertains to the second of two devices use during different procedures.It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a transvaginal mesh retropubic sling placement + cystoscopy procedure performed on (b)(6) 2017 to treat stress urinary incontinence.During the operation, left trocar placement was difficult.It was repositioned and passed again.Upon cystourethroscopy, there was a small bladder puncture on the left but no trocar was present.

• Brand Name: LYNX 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16619984
• MDR Text Key: 312127363
• Report Number: 3005099803-2023-01455
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• 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: 03/27/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0021093264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• 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: 46 YR
• Patient Sex: Female