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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 Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2019
Event Type  malfunction  
Event Description
It was reported that the sling would continue to come off of the trocar inside the body so we could not pass it through the perineal body.Another sling was implanted to complete the surgery.Boston scientific has been unable to obtain additional information regarding the circumstances.
 
Event Description
It was reported that the sling would continue to come off of the trocar inside the body so we could not pass it through the perineal body.Another sling was implanted to complete the surgery.Boston scientific has been unable to obtain additional information regarding the circumstances.
 
Manufacturer Narrative
Device evaluation: the complaint component was returned and analyzed.The reported allegation of malfunction was confirmed via product analysis.No escalation to ncep, capa, or scar is required.
 
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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 Key8533839
MDR Text Key142626706
Report Number2183959-2019-62403
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 08/01/2019
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 Date11/14/2019
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0023372486
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2019
Initial Date Manufacturer Received 03/22/2019
Initial Date FDA Received04/19/2019
Supplement Dates Manufacturer Received07/31/2019
Supplement Dates FDA Received08/01/2019
Patient Sequence Number1
Patient Age71 YR
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