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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS STANDARD CATHETER SET; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
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VARIAN MEDICAL SYSTEMS STANDARD CATHETER SET; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED Back to Search Results
Model Number AL13113002
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2019
Event Type  malfunction  
Event Description
An event took place while treating the last fraction (fx3) of a multi-catheter breast implant with 14 catheters.The dummy sequence took place without any errors or faults, and the video camera was zoomed in on the catheters.We visually confirmed that the dummy wire entered the correct catheter each time, which is the typical practice.After the dummy sequence ended, we zoomed out the camera, so we can see and monitor the patient.The treatment took place uneventfully until catheter no.9, when the patient reported by voice that something touched her.We immediately stopped the treatment and zoomed in.At that time the wire was outside of patient's body hanging over the neck by about 10cm.After entering the room, we inspected catheter no.9 and it was connected properly, as all the others.Was only after disconnecting the quick connect, that we discovered what happened: the plastic catheter kinked and the wire managed to push through, puncturing the catheter.
 
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Brand Name
STANDARD CATHETER SET
Type of Device
SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
Manufacturer (Section D)
VARIAN MEDICAL SYSTEMS
911 hansen way
palo alto CA 94304
MDR Report Key9785485
MDR Text Key181938857
Report Number9785485
Device Sequence Number1
Product Code JAQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberAL13113002
Device Catalogue NumberAL13113002
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2020
Event Location Hospital
Date Report to Manufacturer03/04/2020
Type of Device Usage N
Patient Sequence Number1
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