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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 08/13/2021
Event Type  malfunction  
Event Description
It was reported that during insertion the mesh from sling ripped when trying to apply tension.It was stated that excessive force was not the reason of the rupture.There was no patient complications and the procedure completed using alternate method or device.
 
Manufacturer Narrative
Investigation summary: based on the information available, boston scientific concludes that the identified sheath torn at the sheath-sling adhesive bond edge was most probably caused due to an unintended use error.Product analysis confirmed a device issue.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: visual inspection of the sling and sheath was completed.The sling was concluded to be torn distal of the sheath near the center of the sling as necking of the mesh and stretching of the fibers was apparent.The adhesive bond on the proximal end was intact and bonded to the sheath.A torn sheath will exhibit elongation and deformation of the mesh along with irregular fiber lengths.It is most probable that the patient's anatomy and the physician's technique could be contributing factors to this separation.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed the reported break, and a product issue was identified.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the sling instructions for use (ifu).Investigation conclusion: based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
 
Event Description
It was reported that during insertion the mesh from sling ripped when trying to apply tension.It was stated that excessive force was not the reason of the rupture.There was no patient complications and the procedure completed with a back up of the same product.No further information was provided.
 
Manufacturer Narrative
Information updated: describe event or problem.
 
Event Description
It was reported that during insertion the mesh from sling ripped when trying to apply tension.It was stated that excessive force was not the reason of the rupture.There was no patient complications and the procedure completed with a back up of the same product.No further information was provided.
 
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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
MDR Report Key12438390
MDR Text Key270285714
Report Number2124215-2021-26916
Device Sequence Number1
Product Code OTM
UDI-Device Identifier00878953005560
UDI-Public00878953005560
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 09/20/2021
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 Date02/02/2022
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0027207488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2021
Initial Date Manufacturer Received 08/16/2021
Initial Date FDA Received09/08/2021
Supplement Dates Manufacturer Received08/16/2021
09/17/2021
Supplement Dates FDA Received09/15/2021
09/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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