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 PROXI; CATHETER, CONTINUOUS FLUSH
  • 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 PROXI; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 109676-001
Device Problems Output Problem (3005); Priming Problem (4040)
Patient Problem Insufficient Information (4580)
Event Date 07/01/2021
Event Type  malfunction  
Event Description
The thrombectomy suction catheter of the angiojet solent proxi thrombectomy set had to be primed for 15 seconds while submerged in water.The technologist prepping the thrombectomy suction catheter had to repeat the priming several times because it would get to about 10 and then show an error in the console.A second thrombectomy suction catheter was opened and the technologist was able to complete the priming.But, when the catheter was loaded on a wire and into the patient's vessel, it errored out again.Because of patient safety and all the errors, the physician chose not to use angiojet solent proxi thrombectomy set.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANGIOJET SOLENT PROXI
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12273510
MDR Text Key264999863
Report Number12273510
Device Sequence Number1
Product Code KRA
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 07/29/2021
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 Model Number109676-001
Device Catalogue Number109676-001
Device Lot Number26786158
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/29/2021
Event Location Hospital
Date Report to Manufacturer08/04/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-