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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Hematuria (2558)
Event Date 02/07/2023
Event Type  Injury  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event, as no event date was reported.The complainant was unable to provide the suspected device lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf patient code e2006 captures the reportable event of mesh erosion through the bladder wall.Imdrf impact code f12 captures the reportable event of erosion of mesh and plans to remove the exposed mesh.
 
Event Description
It was reported to boston scientific corporation that an advantage fit blue system was implanted into the patient during a procedure performed on (b)(6) 2020.It was reported that the patient visited the physician due to intermittent hematuria few months ago, which was an intermittent issue that seemed to resolve on its own.Upon cystoscopy, the physician observed that there was a less than 1 cm blue mesh exposure on the right lateral wall of the bladder with mild calcification of the exposed mesh.Subsequently, the physician plans to endoscopically remove the exposed mesh.The patient had no prior physical concerns and is completely continent.
 
Manufacturer Narrative
Blocks b5 and d7a have been updated on the new information received on march 7, 2023.Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspected device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e2006 captures the reportable event of mesh erosion through the bladder wall.Imdrf impact code f12 captures the reportable event of erosion of mesh and plans to remove the exposed mesh.
 
Event Description
It was reported to boston scientific corporation that an advantage fit blue system was implanted into the patient during a procedure performed on (b)(6) 2020.It was reported that the patient visited the physician due to intermittent hematuria few months ago, which was an intermittent issue that seemed to resolve on its own.Upon cystoscopy, the physician observed that there was a less than 1 cm blue mesh exposure on the right lateral wall of the bladder with mild calcification of the exposed mesh.Subsequently, the physician plans to endoscopically remove the exposed mesh.The patient had no prior physical concerns and is completely continent.**additional information received on march 7, 2023: the was implanted in mid-urethra for the treatment of stress urinary incontinence.Cystoscopy was performed for the evaluation of hematuria; otherwise, the patient received no other treatment or diagnostic evaluation.There were no treatments performed since the patient was asymptomatic.The surgery date for removal of the exposed mesh is tentative.
 
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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
2546 calle primera
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16500489
MDR Text Key310852544
Report Number3005099803-2023-01008
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 03/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM0068502120
Device Catalogue Number850-212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2023
Initial Date FDA Received03/07/2023
Supplement Dates Manufacturer Received03/07/2023
Supplement Dates FDA Received03/30/2023
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
Patient SexFemale
Patient Weight66 KG
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