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 Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an advantage fit blue system device was used during a mid-urethral sling procedure performed on (b)(6), 2023, for the treatment of stress incontinence.During the procedure, it was reported that the patient had an extremely small introitus.The retropubic sling could not advance due to the restrictive size of where the device needs to be implanted.Physician could not drop handle of the trocar to advance the sling in the correct position.The procedure was completed using a non-bsc product and there were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a150205 captures the reportable event of a device difficult to advance.

• 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: 17725059
• MDR Text Key: 323126920
• Report Number: 3005099803-2023-04667
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068502120
• Device Catalogue Number: 73189
• Device Lot Number: 0029952863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 117 KG