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 ANGIOJET SOLENT DISTA; CATHETER, EMBOLECTOMY
  • 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 ANGIOJET SOLENT DISTA; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45030
Medical Device Problem Code Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/29/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet solent dista catheter was selected for a thrombectomy procedure.During priming, an error message occurred.The catheter never entered the patient but was already sedated when the issue occurred.No other catheter was available so the procedure was cancelled.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANGIOJET SOLENT DISTA
Common Device Name
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10397289
Report Number2134265-2020-10924
Device Sequence Number19514867
Product Code DXE
UDI-Device Identifier08714729889731
UDI-Public08714729889731
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K113363
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/12/2020
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
Operator of Device Health Professional
Device Expiration Date04/18/2022
Device Model Number45030
Device Catalogue Number45030
Device Lot Number0025626032
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2020
Initial Report FDA Received Date08/12/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-