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

Model Number M0068502120

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981); Positioning Problem (3009); Material Split, Cut or Torn (4008)

Patient Problems Urinary Retention (2119); Dysuria (2684)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0414 captures the reportable event of the persistence of the plastic strip at the vaginal level imdrf patient code e1309 captures the reportable event of urinary retention.Imdrf patient code e1301 captures the reportable event of difficulty urinating.Imdrf impact code f1905 captures the reportable event of loosening too tight tvt mesh.Imdrf impact code f08 captures the reportable event of being re-hospitalized and having to undergo further surgery under anesthesia.

Event Description

It was reported to boston scientific corporation that an advantage fit blue system was implanted into the patient during a procedure performed on (b)(6) 2023.During the procedure, the plastic sheath tore when it was removed.There was persistence of the "plastic strip" at the vaginal level.The physician had to resume by the upper tract to release and pull the sheath, which per the physician, probably twisted the mesh.The patient then had emergency room visits on (b)(6) 2023 for urinary difficulties.On (b)(6) 2023, the patient underwent another surgery to loosen the mesh for urine retention, with a mesh too tight, which in the physician's opinion, was related to this difficulty.The mesh was loosened, but it remained in place.The patient is doing better and has not been seen in the hospital again.

• 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: 17595792
• MDR Text Key: 321645433
• Report Number: 3005099803-2023-04431
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2023

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 Model Number: M0068502120
• Device Catalogue Number: 73189
• Device Lot Number: 0031294201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female