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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 Problem Renal Failure (2041)
Event Date 12/07/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter's city: (b)(6).
 
Event Description
It was reported that the patient had increased creatinine level.An angiojet was selected for a thrombectomy procedure.During procedure, it was noted that there was a very large thrombus burden and the run time was longer than the recommended 240 seconds.The procedure was completed successfully.The patient's urine was cleared the next day post procedure but her creatinine level has risen gradually since the procedure and was at 300.The physician was confident that it would lower down but still concerned that it was so high this long after the procedure.It was also noted that the patient was a little dehydrated pre-procedure.The angiojet machine and catheter performed very well and the doctor was pleased with the result of the procedure but was concerned about the patient's renal function.No further patient complications were reported and patient was improving slightly and her creatinine level was not rising.
 
Event Description
It was reported that the patient had increased creatinine level.An angiojet was selected for a thrombectomy procedure.During procedure, it was noted that there was a very large thrombus burden and the run time was longer than the recommended 240 seconds.The procedure was completed successfully.The patient's urine was cleared the next day post procedure but her creatinine level has risen gradually since the procedure and was at 300.The physician was confident that it would lower down but still concerned that it was so high this long after the procedure.It was also noted that the patient was a little dehydrated pre-procedure.The angiojet machine and catheter performed very well and the doctor was pleased with the result of the procedure but was concerned about the patient's renal function.No further patient complications were reported and patient was improving slightly and her creatinine level was not rising.
 
Manufacturer Narrative
Updated: h6 - evaluation method codes.Batch lot number: either 23905759 or 23949105.E1: initial reporter's city: (b)(6).
 
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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 Key9538911
MDR Text Key173337410
Report Number2134265-2019-16161
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,foreig
Type of Report Initial,Followup
Report Date 03/17/2020
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/16/2019
Initial Date FDA Received01/02/2020
Supplement Dates Manufacturer Received02/27/2020
Supplement Dates FDA Received03/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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