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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2023
Event Type  malfunction  
Event Description
It was reported that the patient underwent surgical implantation of a sling device, when the sling broke.The physician was passing the sheath through to the inner thigh position using a helical trocar and the sling broke when partially inserted.The sling was removed, and a new sling was implanted.There were no patient complications reported.
 
Manufacturer Narrative
Upon receipt of the sling at our quality assurance laboratory, the returned component underwent a thorough analysis.Examination of the device showed it was torn distal to the sheath near the center of the sling.The adhesive bond was intact and bonded to the sheath.The sheath showed signs of elongation and deformation of the mesh along with irregular fiber lengths.These findings are most probable with a separation of the sling due to the patient anatomy and the physician technique.There were no other irregularities found with the device.Based on the information available, the analysis confirmed a product malfunction that was consistent with the interaction of the user and the device.
 
Event Description
It was reported that the patient underwent surgical implantation of a sling device, when the sling broke.The physician was passing the sheath through to the inner thigh position using a helical trocar and the sling broke when partially inserted.The sling was removed, and a new sling was implanted.There were no patient complications reported.
 
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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
john stoffregen
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key16329832
MDR Text Key309191122
Report Number2124215-2023-05494
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/25/2023
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 Number720163-01
Device Catalogue Number720163-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/25/2023
Initial Date FDA Received02/08/2023
Supplement Dates Manufacturer Received04/11/2023
Supplement Dates FDA Received04/25/2023
Was Device Evaluated by Manufacturer? Yes
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 Age57 YR
Patient SexMale
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