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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 08/09/2018
Event Type  Death  
Event Description
It was reported that the patient expired.An angiojet zelante catheter was selected for a pharmacomechanical thrombolysis/thrombectomy and venoplasty procedure.The patient presented with complaints of left leg pain and swelling.Reports noted extensive illiofemoral and ivc thrombosis.During the procedure, the initial venoplasty was completed with a 12x40mm balloon.Then, the angiojet catheter was used for around 100 seconds, wherein the patient developed bradycardia with hypotension.The catheter was removed and the patient was transferred to the icu.The patient developed cardiac arrest and immediately intubation was done and cpr started with inotropic support.The patient could not be revived and expired in the icu.The cause of death was reported by the physician as massive pulmonary embolism.
 
Event Description
It was reported that the patient expired.An angiojet zelante catheter was selected for a pharmacomechanical thrombolysis/thrombectomy and venoplasty procedure.The patient presented with complaints of left leg pain and swelling.Reports noted extensive illiofemoral and ivc thrombosis.During the procedure, the initial venoplasty was completed with a 12x40mm balloon.Then, the angiojet catheter was used for around 100 seconds, wherein the patient developed bradycardia with hypotension.The catheter was removed and the patient was transferred to the icu.The patient developed cardiac arrest and immediately intubation was done and cpr started with inotropic support.The patient could not be revived and expired in the icu.The cause of death was reported by the physician as massive pulmonary embolism.
 
Manufacturer Narrative
Additional information reported that the device was used on a previous patient.The device was sterilized using a standard sterilization procedure with ethylene oxide.The reprocessing was done at another hospital.
 
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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 Key9249936
MDR Text Key164112251
Report Number2134265-2019-12819
Device Sequence Number1
Product Code DXE
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,foreig
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number45027
Device Catalogue Number45027
Device Lot Number0021443307
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/04/2019
Initial Date FDA Received10/29/2019
Supplement Dates Manufacturer Received11/11/2019
Supplement Dates FDA Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Death;
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