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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 Insufficient Information (3190)
Patient Problem Perforation (2001)
Event Date 02/04/2020
Event Type  Injury  
Event Description
It was reported that the patient presented stress incontinence with his advance sling.The patient had a urethral injury.Additional information received.The procedure was aborted due to the needle passed through urethra.Urinary incontinence was the baseline that lead to the sling implant procedure.
 
Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.Product analysis could not confirm the reported events related to urethra perforation nor a device malfunction related to the reported events.The product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
 
Event Description
It was reported that the patient presented stress incontinence with his advance sling.The patient had a urethral injury.Additional information received.The procedure was aborted due to the needle passed through urethra.Urinary incontinence was the baseline that leaded to the sling implant procedure.
 
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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
100 boston scientific way
marlborough MA 01752 1242
MDR Report Key9749586
MDR Text Key180722683
Report Number2183959-2020-00863
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
Report Date 03/17/2020
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 Expiration Date09/19/2020
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0024809723
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2020
Initial Date Manufacturer Received 02/04/2020
Initial Date FDA Received02/25/2020
Supplement Dates Manufacturer Received02/26/2020
Supplement Dates FDA Received03/17/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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