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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK TRUEPATH¿; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC - CORK TRUEPATH¿; WIRE, GUIDE, CATHETER Back to Search Results
Model Number H74939208181650
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the outer shaft rotated.The chronic total occlusion was located in the right iliac artery.A truepath¿ cto device was selected for use.During preparation, it was noted that the device stopped and did not spin.When the device was turned on again, a chirping and beeping noise was noticed but the tip did not spin.Furthermore, it was then observed that the outer shaft attempted to spin.The procedure was not completed.No patient complications were reported.
 
Event Description
It was reported that the outer shaft rotated.The chronic total occlusion was located in the right iliac artery.A truepath¿ cto device was selected for use.During preparation, it was noted that the device stopped and did not spin.When the device was turned on again, a chirping and beeping noise was noticed but the tip did not spin.Furthermore, it was then observed that the outer shaft attempted to spin.The procedure was not completed.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a truepath device.There is a presence of blood on the shaft.The control unit, motor housing and working length and tip/tip housing were microscopically examined.There was saline on the shaft and tip of the device.There was no damage or irregularities identified during analysis.The device was soaked in warm water to loosen the solidified saline.Functional testing performed and the device turned on and the normal audible noise was heard, meanwhile the device vibrated and the burr tip rotated with no alert light or issues.When pressure was applied and released the alert lights and audible noise worked properly.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
 
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Brand Name
TRUEPATH¿
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
MDR Report Key7241699
MDR Text Key99095387
Report Number2134265-2018-00484
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
PMA/PMN Number
K101599
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/02/2019
Device Model NumberH74939208181650
Device Catalogue Number39208-18165
Device Lot Number21343172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2018
Date Manufacturer Received02/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age70 YR
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