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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO CONSOLE; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAPRO CONSOLE; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number H74939309010
Device Problem Failure to Shut Off (2939)
Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914)
Event Date 07/01/2021
Event Type  Death  
Event Description
Rotapro cath was inserted and the rotapro machine was turned on, after the second pass the machine would not turn off, staff had to physically unplug the power cables from the console to get the machine to power off.The patient started complaining about chest pain.There was a drop in heartrate and bp.Cpr was started and anesthesia was called for intubation.After about 30 min of cpr the patient had a rhythm and was transported to the 5th floor [icu].Machine sequestered, clinical engineering was not able to reproduce the device staying on by itself, however it was noted that the black circular connector was loose as a result the machine would shut off by itself.The hospital has contacted boston and asked that a boston representative come to the hospital to physically inspect the equipment together with hospital clinical engineering.Fda safety report id# (b)(4).
 
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Brand Name
ROTAPRO CONSOLE
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key12180334
MDR Text Key262162076
Report NumberMW5102557
Device Sequence Number1
Product Code MCX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/14/2021
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 Model NumberH74939309010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/15/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Other;
Patient Age68 YR
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