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 EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC
  • 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 EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 20188
Device Problem Contamination (1120)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 04/01/2019
Event Type  malfunction  
Event Description
It was reported that device contamination occurred.A 6.0mmx18mmx150cm express sd renal/biliary drug eluting was selected for use.However, before it went to the body, the device got contaminated.The procedure was completed with another of same device.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an express sd stented catheter in an opened pouch.The device was removed from the carrier tubing revealing that the balloon was loosely folded.The stent was secured between the markerbands.The opened packaging, hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined.Inspection of the device presented no damage or irregularities.
 
Event Description
It was reported that device contamination occurred.A 6.0mmx18mmx150cm express sd renal/biliary drug eluting was selected for use.However, before it went to the body, the device got contaminated.The procedure was completed with another of same device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EXPRESS SD RENAL/BILIARY
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8546895
MDR Text Key143039818
Report Number2134265-2019-04307
Device Sequence Number1
Product Code NIN
UDI-Device Identifier08714729484844
UDI-Public08714729484844
Combination Product (y/n)N
PMA/PMN Number
K152607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/03/2022
Device Model Number20188
Device Catalogue Number20188
Device Lot Number0023138186
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2019
Date Manufacturer Received07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-