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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY

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BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45031
Device Problems Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.The target lesion was located in the superficial femoral artery.An angiojet solent omni catheter was used in a thrombectomy procedure.Prior to the procedure, it was noted that during priming, saline was leaking from the pump bulb.The device was reset but still could not prime.The procedure was then cancelled and rescheduled for the following day.No patient complications were reported.
 
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Brand Name
ANGIOJET SOLENT OMNI
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13442581
MDR Text Key285165339
Report Number2134265-2022-00965
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729889663
UDI-Public08714729889663
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/03/2022
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 Expiration Date08/30/2023
Device Model Number45031
Device Catalogue Number45031
Device Lot Number0028230212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2022
Initial Date FDA Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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