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 ASCERTA; STENT, URETERAL
  • 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 ASCERTA; STENT, URETERAL Back to Search Results
Model Number M0061456130
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2016
Event Type  malfunction  
Event Description
While performing cystoscopy, there was difficulty accessing the ureter because of the deformity of position from the massive cystocele.Was able to get a 0.035 glidewire into the ureter; however there was some hold up on passing the ureteral catheter about 3 to 4 cm from the ureterovesical-junction (uvj) on the right.Used a dilating ureteral catheter up to an 8-french on the right side and this facilitated passage of a 6 x 24-cm double-j stent which was left in place without a dangler.The string on the stent pulled away after it was placed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASCERTA
Type of Device
STENT, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC
100 boston scientific way
marlborough, MA 01752
MDR Report Key5652273
MDR Text Key45132810
Report Number5652273
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/06/2016
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 Physician
Device Model NumberM0061456130
Device Lot Number18945334
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/06/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age79 YR
Patient Weight70
-
-