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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; SURGICAL MESH
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BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; SURGICAL MESH Back to Search Results
Catalog Number 720163-01
Device Problem Torn Material (3024)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/08/2018
Event Type  malfunction  
Event Description
It was reported that following the placement of the advance xp sling, the right plastic sheath "ruptured" during removal using 'soft traction'.A more proximal removal attempt of the sheath was made, which resulted in a second 'rupture'.A fragment of plastic sheath remained around the mesh with in the right obturator hole.There were no immediate patient consequences.No patient complications reported in relation to this event.
 
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Brand Name
AMS ADVANCE XP SLING SYSTEM
Type of Device
SURGICAL MESH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key7211595
MDR Text Key98091964
Report Number2183959-2018-00017
Device Sequence Number1
Product Code OTM
UDI-Device Identifier00878953005560
UDI-Public00878953005560
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/15/2018
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 Lay User/Patient
Device Expiration Date06/30/2018
Device Catalogue Number720163-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/15/2018
Initial Date FDA Received01/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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