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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Renal Failure (2041)
Event Date 04/01/2023
Event Type  Injury  
Event Description
It was reported that renal failure occurred.The target lesion was located in the upper limb deep vein thrombosis.An angiojet device was used for thrombectomy procedure.The patient experienced acute kidney injury (aki) and dialysis till renal recovery.The patient had undergone intensive care unit.There were no patient complications reported.
 
Manufacturer Narrative
Event date: used the first date of the month of the aware date as no event date was provided.
 
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Brand Name
ANGIOJET
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16897445
MDR Text Key314854085
Report Number2124215-2023-20015
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/09/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received05/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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