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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORINDUS, INC. CORPATH 200 SYSTEM
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CORINDUS, INC. CORPATH 200 SYSTEM Back to Search Results
Catalog Number 160-00043
Device Problem Fail-Safe Problem (2936)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2016
Event Type  malfunction  
Event Description
The guidewire joystick would not return to its neutral position for rotation and the guidewire continued to rotate without user actuation of the joystick.When the joystick was forced to return to its neutral position, the rotation actuation mechanism ceased to function.
 
Manufacturer Narrative
The user over-torqued the joystick causing the shaft to break its adhesion within the joystick spindle.The torque on the spring pin within the cap caused its residing hole to deform, elongating the hole and making it unable to contain the pressed pin any further.
 
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Brand Name
CORPATH 200 SYSTEM
Type of Device
CORPATH 200 SYSTEM
Manufacturer (Section D)
CORINDUS, INC.
309 waverley oaks road
suite 105
waltham MA 02452
Manufacturer (Section G)
CORINDUS, INC.
309 waverley oaks road
suite 105
waltham MA 02452
Manufacturer Contact
robert lavado
309 waverley oaks road
suite 105
waltham, MA 02452
5086533335
MDR Report Key6227199
MDR Text Key64016282
Report Number3007822508-2016-00025
Device Sequence Number1
Product Code DXX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120834
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial,Followup
Report Date 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number160-00043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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