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 OMNI; 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 OMNI; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45031
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2024
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.An angiojet solent omni catheter was selected for use in a thrombectomy procedure.While preparing the catheter, the barcode on the angiojet solent omni could not be read.A second angiojet solent omni was selected for use.However, the same problem occurred.The procedure was cancelled.
 
Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis was completed.The returned product consisted of an angiojet solent omni catheter.Inspection of the device revealed no damage or irregularities.The complaint was not confirmed for any pump leaks, set-up issues or alarm messages.
 
Event Description
It was reported that the procedure was cancelled.An angiojet solent omni catheter was selected for use in a thrombectomy procedure.While preparing the catheter, the barcode on the angiojet solent omni could not be read.A second angiojet solent omni was selected for use.However, the same problem occurred.The procedure was cancelled.It was further reported that only local anesthesia was used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANGIOJET SOLENT OMNI
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19140177
MDR Text Key340646450
Report Number2124215-2024-22932
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/09/2024
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 Number45031
Device Catalogue Number45031
Device Lot Number0032823302
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/29/2024
Initial Date FDA Received04/18/2024
Supplement Dates Manufacturer Received04/19/2024
Supplement Dates FDA Received05/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
Patient SexFemale
-
-