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 CONTOUR; 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 CORPORATION CONTOUR; STENT, URETERAL Back to Search Results
Model Number M0061802240
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2019
Event Type  malfunction  
Event Description
Patient for left percutaneous nephrolithotomy and right cystoscopy, retrograde pyelogram, ureteroscopy, laser lithotripsy, basket stone extraction, ureteral stent exchange.3 stents used for procedure.Md asked the scrub tech to send two ureteral stents back to boston scientific.Scrub tech gave circulating rn the fr6 x 26cm and fr6 x 28cm.During sign out after case was done, circulating rn asked doctor regarding the two ureteral stents she wanted to send back to boston scientific.Doctor stated the loops failed.No patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONTOUR
Type of Device
STENT, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key8394047
MDR Text Key137942641
Report Number8394047
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0061802240
Device Catalogue NumberM0061802240
Device Lot Number23044249
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/27/2019
Event Location Hospital
Date Report to Manufacturer03/06/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age15695 DA
-
-