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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 Problem Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2019
Event Type  malfunction  
Event Description
It was reported that loss of aspiration occured.An angiojet zelantedvt was advanced for a thrombectomy procedure.During procedure, it was noted that the device stopped suctioning after 67cc.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the zelantedvt thrombectomy.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Blood was present inside the device and 200ml of blood in the attached waste bag, when received.Inspection of the device revealed that the hypotube and shaft were kinked 17.7cm and 18.4cm distal of the strain relief.Functional testing was performed by placing the device in the angiojet ultra console.Testing consisted of running the complaint device through the full priming cycle and 120 seconds in thrombectomy and power pulse mode for 60 seconds.The device ran within normal range without any leaks from the boot/pump assembly or device or any errors/alarms from the console.There was no issues with the suction and no fluid escaped into the waste bag during power pulse mode.
 
Event Description
It was reported that loss of aspiration occured.An angiojet zelantedvt was advanced for a thrombectomy procedure.During procedure, it was noted that the device stopped suctioning after 67cc.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
 
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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 Key9586853
MDR Text Key177409844
Report Number2134265-2020-00090
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729904724
UDI-Public08714729904724
Combination Product (y/n)N
PMA/PMN Number
K151313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/07/2020
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
Device Operator Health Professional
Device Expiration Date11/05/2021
Device Model Number45027
Device Catalogue Number45027
Device Lot Number0024865176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Initial Date Manufacturer Received 12/30/2019
Initial Date FDA Received01/14/2020
Supplement Dates Manufacturer Received01/24/2020
Supplement Dates FDA Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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