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 720163-01
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2022
Event Type  malfunction  
Event Description
It was reported that during the implant procedure for this sling, the kit opened was missing the sling.The procedure was not able to be performed without the device; therefore, it was rescheduled.It was indicated that the patient had already been administered general anesthesia when the procedure was cancelled.There were no patient complications.This event is being reported for a cancelled procedure with the patient under general anesthesia.
 
Event Description
It was reported that the box for a sling kit was opened for an unrelated implant procedure in which the device had not been implanted due to patient anatomy.As the materials in the box were sterile, the facility returned the opened box to storage.During a different sling implant surgery, the previously opened box was going to be used; however, the kit was missing the sling.It was suspected that the device fell after the box had been initially opened.The procedure was not able to be performed without the device; therefore, it was rescheduled.It was indicated that the patient had already been administered general anesthesia when the procedure was cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this advance xp kit underwent a thorough analysis.Visual analysis noted that the kit returned only contained the disposable retractor ring and 8 elastic stays 12mm blunt hooks.The packages were sealed tight, and no visual damages were identified upon inspection.The advance xp male sling system device directions for use (dfu) states: do not use the advance xp male sling system if the package is opened or damaged, as sterility may be compromised.The advance xp male sling system must not be re-sterilized or re-used.Based on the information available and analysis results, the reported allegation of the kit missing the sling was confirmed; however, a conclusion code of failure to follow instructions was assigned to this investigation.As the event was traced to the user not following the manufacturer's instructions.
 
Event Description
It was reported that the box for a sling kit was opened for an unrelated implant procedure in which the device had not been implanted due to patient anatomy.As the materials in the box were sterile, the facility returned the opened box to storage.During a different sling implant surgery, the previously opened box was going to be used; however, the kit was missing the sling.It was suspected that the device fell after the box had been initially opened.The procedure was not able to be performed without the device; therefore, it was rescheduled.It was indicated that the patient had already been administered general anesthesia when the procedure was cancelled.There were no patient complications.
 
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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key15813004
MDR Text Key303831966
Report Number2124215-2022-47587
Device Sequence Number1
Product Code OTM
UDI-Device Identifier00878953005560
UDI-Public00878953005560
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/02/2023
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 Date05/03/2023
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0029754542
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2022
Initial Date FDA Received11/17/2022
Supplement Dates Manufacturer Received11/16/2022
02/09/2023
Supplement Dates FDA Received12/08/2022
03/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
-
-