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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ZELANTEDVT; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET ZELANTEDVT; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45027
Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was rescheduled.The target lesion was located in the iliac vein.An angiojet zelantedvt was selected for a thrombectomy procedure.During preparation, after priming for 12 seconds, the device alerted check saline supply error and found a leakage near the pump.The procedure was rescheduled and patient was already sedated.The procedure was completed the next day.No patient complications were reported and patient's status was stable.
 
Manufacturer Narrative
Updated: b5 - describe event or problem.
 
Event Description
It was reported that the procedure was rescheduled.The target lesion was located in the iliac vein.An angiojet zelantedvt was selected for a thrombectomy procedure.During preparation, after priming for 12 seconds, the device alerted check saline supply error and found a leakage near the pump.The procedure was rescheduled and patient was already sedated.The procedure was completed the next day.No patient complications were reported and patient's status was stable.It was further reported that the catheter was connected to the console and after it was connected, the console alarmed.The procedure was completed after replacing the catheter.
 
Event Description
It was reported that the procedure was rescheduled.The target lesion was located in the iliac vein.An angiojet zelantedvt was selected for a thrombectomy procedure.During preparation, after priming for 12 seconds, the device alerted check saline supply error and found a leakage near the pump.The procedure was rescheduled and patient was already sedated.The procedure was completed the next day.No patient complications were reported and patient's status was stable.It was further reported that the catheter was connected to the console and after it was connected, the console alarmed.The procedure was completed after replacing the catheter.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet zalante catheter.A.035 guidewire was stuck in the device when returned.The pump assembly, effluent/supply line, shaft, tip and spike line were visually examined for damage or any irregularities.The outer shaft showed no damage.Functional testing was competed per the device preparation.The pump was inserted into the ultra drive unit console.The pump and the device primed and were run for a period of 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.During functional testing no errors or priming issues were noticed, the device ran as designed.Inspection of the remainder of the device revealed no damage or irregularities.
 
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Brand Name
ANGIOJET ZELANTEDVT
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11214905
MDR Text Key228214275
Report Number2134265-2021-00607
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 03/17/2021
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 Expiration Date09/24/2022
Device Model Number45027
Device Catalogue Number45027
Device Lot Number0026161422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2021
Initial Date Manufacturer Received 01/11/2021
Initial Date FDA Received01/22/2021
Supplement Dates Manufacturer Received01/27/2021
02/25/2021
Supplement Dates FDA Received02/23/2021
03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age48 YR
Patient Weight66
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