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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 Difficult to Remove (1528); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on an unknown date.The plastic sheath did not release throughout the surgery; thus, it was stretched and tore.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Manufacturer Narrative
Block b3 date of event: approximated based on the date the manufacturer became aware of the event.Block h6: device code a0414 captures the reportable event of sleeve torn.Block h10: a visual inspection of the returned device showed that the dilators were separated with a clean cut and the mesh was in two pieces and not in the sleeve.The mesh had signs of it being stretched.Therefore, the complaint was confirmed.Based on the available information, it is likely that the procedural handling and use of device caused the resulted condition.The observation of the dilators being separated with a clean-cut show that the tab attached to the dilator was not cut as advised in the ifu, "grasp the blue centering tab and cut the tab through the center of the punch hole ensuring that both halves of the blue tab are completely removed from the vaginal canal." this may have led to the sheath not being able to be released during the procedure thus stretching and tearing the mesh.Moreover, this may have led to the sheath not being able t be released during the procedure thus stretching and tearing of mesh.The most probable cause for this finding is adverse event related to procedure as the problem could be caused by the user due to the manipulation, handling, interaction of the device during the procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on an unknown date.The plastic sheath did not release throughout the surgery; thus, it was stretched and tore.There were no patient complications reported as a result of this event.
 
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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
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14724150
MDR Text Key294522214
Report Number3005099803-2022-03290
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 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/04/2023
Device Model NumberM0068502110
Device Catalogue Number850-211
Device Lot Number0025160279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2020
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 Age41 YR
Patient SexFemale
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