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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068502110
Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2023
Event Type  malfunction  
Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of twisted mesh.
 
Event Description
It was reported to boston scientific corporation that an advantage fit system was used during a mid-urethral sling placement for the treatment of a stress urinary incontinence (sui) procedure performed on (b)(6) 2023.During the procedure, the mesh twisted within the sheath.It was not reported how the procedure was completed.
 
Event Description
It was reported to boston scientific corporation that an advantage fit system was used during a mid-urethral sling placement for the treatment of a stress urinary incontinence (sui) procedure performed on (b)(6) 2023.During the procedure, the mesh twisted within the sheath.It was not reported how the procedure was completed.Additional information received on november 17, 2023: the problem was noticed during the unpacking of the device.The procedure was completed with another of the same device.There were no patient complications as a result of the event.
 
Manufacturer Narrative
Blocks b5 and h6 have been updated based on the new information received on november 17, 2023.Block h6: imdrf device code a040609 captures the reportable event of twisted mesh.
 
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Brand Name
ADVANTAGE FIT 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
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18148553
MDR Text Key328282225
Report Number2124215-2023-62730
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729772880
UDI-Public08714729772880
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0068502110
Device Catalogue Number850-211
Device Lot Number0032036726
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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