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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number 720163-01
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/24/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that during the procedure to implant this sling device, the right branch of the strip broke approximately 1 cm from the flared portion.The remaining end of the strip was able to be secured satisfactorily.It was stated the broken portion of the sling was not preserved; it is unclear if any portion remains unsecured in the patient.There were no irregularities observed with the sling when inspected upon removal from the box.There were no reported patient complications.No additional information was reported.
 
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Brand Name
AMS ADVANCE XP SLING SYSTEM
Common Device Name
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752 1242
MDR Report Key11382056
Report Number2183959-2021-00685
Device Sequence Number3847462
Product Code OTM
UDI-Device Identifier00878953005560
UDI-Public00878953005560
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/25/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date03/31/2021
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0025905405
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/10/2021
Initial Report FDA Received Date02/25/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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