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 Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

A photo of the two layers of label was provided to bsc.The photo showed two lot numbers: 23412939 and underneath it was 22655292.Expiration dates were not shown in the photo.Although the customer reported an expiration date for 22655292, the bsc system confirmed that both reported lot numbers have an expiration date of 2021.Lot no.23412939.Brand name: advantage fit blue system.Upn: m0068502120.Manufacture date: 02/27/2019.Use before date/expiration: 09/13/2021.Lot no.22655292.Brand name: advantage fit blue system.Upn: m0068502120.Manufacture date: 09/14/2018.Use before date/expiration: (b)(4) 2021.(b)(4).The complainant indicated that the device is implanted and is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an advantage fit blue system device was implanted into the patient during a mid-urethral sling procedure performed on (b)(6) 2020.According to the complainant, after the procedure, it was noticed that there were two stickers of the label with different lot numbers on the device package.Reportedly, the expiration date indicated in the underneath label was 2018.There were no patient complications reported after the procedure.The condition of the patient after the procedure was reported to be stable.

• 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: 10877239
• MDR Text Key: 223454412
• Report Number: 3005099803-2020-05437
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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