VIPER GUIDE WIRE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for VIPER GUIDE WIRE manufactured by Cardiovascular Systems Incorporated.

Event Text Entries

[183635320] On the date (b)(6) 2014 i underwent a heart catheter to open clogged arteries. During the procedure the catheter guide wire was sheared where it remains today. While i was in recovery i was made aware of the seemingly inconsequential nature of it. All was forgotten until (b)(6) 2020 when i was reviewing upcoming events. I was scheduled to a mri on (b)(6) 2020. Reviewing the questions asked when making the appointment (weeks earlier) i recalled the question do you have any injuries. I answered no. Not thinking of that wire. On the evening of i called the cardiologist office and left a message for the cardiologist to call me. I wanted to know what the wire was made of and was it magnetically attracted. The following morning a technician from that office emailed me a photo of the package that the viper guidewire comes in. On the package it plainly states stainless steel. I wanted to know what alloy stainless steel given that 300 series is non-magnetically attached and 400 series are. I called the manufacture csi. Csi could not immediately tell me the alloy. Later that day csi via email stated 304 as i was pleased. However i did not sleep that thursday night thinking of that war. The next morning i put together a test and work hard in the wire form that they do when they make this tool. When waving a magnet over the wire in the fashion that they manufacture i was able to connect it to the magnet. I immediately got in touch with the cardiologist and showed him my work. He realized at the moment that wire would cause harm in an mri. This wire when severed or broken should never remain in the patient and the patient must be given a med alert against ever getting an mri for it will probably cause instant death. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093699
MDR Report Key9823719
Date Received2020-03-11
Date of Report2020-03-09
Date of Event2014-08-29
Date Added to Maude2020-03-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIPER GUIDE WIRE
Generic NameCATHETER, PRIPHERAL, ATHERECTOMY
Product CodeMCW
Date Received2020-03-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARDIOVASCULAR SYSTEMS INCORPORATED


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-03-11

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