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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
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2022
Event Type  malfunction  
Event Description
It was reported that during a male sling procedure, the sheet and paper protecting the sling arms came off sooner than the physician wanted.The physician tried to taper the mesh with the sling arms alone, but the sling was not able to achieve the appropriate coaptation when tightening the sling arms.The sling arms began stretching and unraveling; therefore, the physician decided to replace it with a new sling.The procedure was completed without patient complications.
 
Event Description
It was reported that during a male sling procedure, the sheet and paper protecting the sling arms came off sooner than the physician wanted.The physician tried to taper the mesh with the sling arms alone, but the sling was not able to achieve the appropriate coaptation when tightening the sling arms.The sling arms began stretching and unraveling; therefore, the physician decided to replace it with a new sling.The procedure was completed without patient complications.
 
Event Description
It was reported that during a male sling procedure, the sheet and paper protecting the sling arms came off sooner than the physician wanted.The physician tried to taper the mesh with the sling arms alone, but the sling was not able to achieve the appropriate coaptation when tightening the sling arms.The sling arms began stretching and unraveling; therefore, the physician decided to replace it with a new sling.The procedure was completed without patient complications.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory the device underwent a through analysis.Visual examination identified the sling sheath was cut which is expected as part of the procedure.Elongation and tearing of the mesh fibers was observed which is consistent with over tensioning of the device, confirming the reported clinical observation during procedure.Based on the information available and analysis results, the interaction between the user and device caused or contributed to the reported event and observed sling damages.
 
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Brand Name
AMS ADVANCE XP SLING SYSTEM
Type of Device
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
4089353452
MDR Report Key13973282
MDR Text Key288355189
Report Number2124215-2022-09285
Device Sequence Number1
Product Code OTM
UDI-Device Identifier00878953005560
UDI-Public00878953005560
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/16/2022
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 Expiration Date12/13/2022
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0028821259
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2022
Initial Date FDA Received04/01/2022
Supplement Dates Manufacturer Received04/01/2022
04/26/2022
Supplement Dates FDA Received04/04/2022
05/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2021
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 Age62 YR
Patient SexMale
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