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

Model Number M0068502120

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

Patient Problems Abscess (1690); Hematoma (1884); Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2023, was chosen as the best estimate based on the revision date.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e0206 captures the reportable event of embarrassment, disfigurement and harm.Imdrf patient code e2401 captures the reportable event of severe and debilitating injuries, serious bodily injury and suffering.Imdrf patient code e172001 captures the reportable event of retropubic abscess.Imdrf patient code e0505 captures the reportable event of retropubic hematoma.Imdrf impact code f2203 captures the reportable event of cystourethroscopy.Imdrf impact code f1905 captures the reportable event of revision and removal of mid urethral sling.

Event Description

It was reported to boston scientific corporation that an advantage fit blue mid-urethral sling system device was used during a transvaginal surgery performed on (b)(6) 2023.The patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm from the implanted mesh.The patient has sustained and will continue to sustain severe and debilitating injuries, serious bodily injury, mental and physical pain and suffering, and has incurred economic loss.As a result of the implanted mesh, the patient has experienced significant mental and physical pain and suffering and has sustained permanent injury.Additional information received on october 5, 2023: after the patient had a mid-urethral sling procedure and cystourethroscopy on (b)(6) 2023, the ir drain was removed on (b)(6) 2023, after improvement of her symptoms.But shortly after removal, the patient developed a fever.Additionally, the patient developed postoperative hematoma six weeks postop and underwent ir drainage on (b)(6) 2023.The culture was sent and had no growth.Findings were consistent with retropubic hematoma.On (b)(6) 2023, the patient underwent a revision and removal of mid-urethral sling and cystourethroscopy due to a retropubic abscess.During the mesh removal procedure, no purulent drainage, no obvious signs of infection or inflammation were noted.The patient tolerated the procedure well.She was then awoken from anesthesia and transferred to the pacu in stable condition.

• Brand Name: ADVANTAGE FIT BLUE 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: 17988216
• MDR Text Key: 326308740
• Report Number: 3005099803-2023-05611
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502120
• Device Catalogue Number: 73189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention