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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068502120
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an advantage fit blue system device was used during the insertion of a mid-urethral sling procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.During the procedure, the surgeon passed the first arm of the sling successfully.When attempting to pass the second arm of the sling, the surgeon noticed that the needle was bent.The procedure was completed using a non-boston scientific device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of needle bent.
 
Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of a needle being bent.Block h10: the returned capio slim device was analyzed, and it was found that the delivery device and mesh were in good condition.However, during visual inspection, it was found that one of the dilator tips was bent.Therefore, the reported event of "needle bent" was confirmed.With all the available information, boston scientific concludes that it is likely that excessive pulling force was applied during the placement of the mesh, resulting in the analyzed device condition of the dilator being bent.The procedure was completed using another device.Therefore, the probable cause selected is "adverse event related to procedure," which indicates that the adverse event occurred during the procedure and the device did not influence the event.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that an advantage fit blue system device was used during the insertion of a mid-urethral sling procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.During the procedure, the surgeon passed the first arm of the sling successfully.When attempting to pass the second arm of the sling, the surgeon noticed that the needle was bent.The procedure was completed using a non-boston scientific device.There were no patient complications reported as a result of this event.
 
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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 Key17364163
MDR Text Key319715206
Report Number3005099803-2023-03925
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729961925
UDI-Public08714729961925
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 08/31/2023
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 NumberM0068502120
Device Catalogue Number73189
Device Lot Number0030264219
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/05/2023
Initial Date FDA Received07/20/2023
Supplement Dates Manufacturer Received08/11/2023
Supplement Dates FDA Received08/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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