Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number UNK-M-720163-01
Device Problems Break (1069); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
Patient Problems Complaint, Ill-Defined (2331); Device Embedded In Tissue or Plaque (3165)
Event Date 12/04/2019
Event Type  Injury  
Event Description
It was reported that the surgeon was implanting an advance xp sling, and had difficulty passing the helical needle through the patient's left side.The surgeon managed to pass and adapt the sling on the needle, but extraction and maneuvering was also a complicated one.Eventually the connection broke, and a part of the sheath remained inside the patient.The doctor tried to recover the connection, but he was unsuccessful.There was no reported patient bleeding associated with this event.The surgeon will be using another new advance xp to complete procedure.
 
Event Description
It was reported that the surgeon was implanting an advance xp sling, and had difficulty passing the helical needle through the patient's left side.The surgeon managed to pass and adapt the sling on the needle, but extraction and maneuvering was also a complicated one.Eventually the connection broke, and a part of the sheath remained inside the patient.The doctor tried to recover the connection, but he was unsuccessful.There was no reported patient bleeding associated with this event.The surgeon will be using another new advance xp to complete procedure.
 
Manufacturer Narrative
Correction on h6-pateint code.
 
Manufacturer Narrative
Correction on h6-device code, b1, d5.D10, h3, h6, h10.H3 device evaluation: the advance xp sling returned with one connector present and attached to the sling.Visual inspection of the sling, sheath and connector (1) was completed.The sheath was identified to be torn at the sheath-sling adhesive bond edge.The connector (2) that "broke" during implant was not returned resulting in product analysis unable to confirm a device malfunction with the connector; however, analysis did confirm a tear in the sheath.Two needle passers (trocars) also returned; visual inspection was completed.No abnormalities nor malfunctions with the needle passers were identified.The connector(1) that returned was functionally tested with a needle passer and confirmed to snap into place.Product analysis confirmed the reported sheath tear.
 
Event Description
It was reported that the surgeon was implanting an advance xp sling, and had difficulty passing the helical needle through the patient's left side.The surgeon managed to pass and adapt the sling on the needle, but extraction and maneuvering was also a complicated one.Eventually the connection broke, and a part of the sheath remained inside the patient.The doctor tried to recover the connection, but he was unsuccessful.There was no reported patient bleeding associated with this event.The surgeon will be using another new advance xp to complete procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9488381
MDR Text Key171798408
Report Number2183959-2019-68225
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 03/22/2020
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? Yes
Device Operator Health Professional
Device Model NumberUNK-M-720163-01
Device Catalogue NumberUNK-M-720163-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2020
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received12/18/2019
Supplement Dates Manufacturer Received12/27/2019
03/14/2020
Supplement Dates FDA Received01/06/2020
03/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-