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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, ultrasound, intravascular
Regulation Description Diagnostic intravascular catheter.
Definition For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Product CodeOBJ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 6
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
JOMED
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 5
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 15

Device Problems
Retraction problem 249
Entrapment of device or device component 101
No display or display failure 78
Use of Device Issue 61
No Known Device Problem 39
Material separation 35
Detachment of device component 25
Improper device output 19
Device operates differently than expected 19
Break 18
False device output 16
Output issue 16
Difficult to remove 15
Incorrect or inadequate result 12
Physical resistance 10
Foreign material present in device 8
Poor quality image 8
Erratic display 7
Kinked 7
Positioning Issue 6
Fluid leak 5
Unable to obtain readings 4
Difficult to advance 4
Detachment of device or device component 3
Torn material 3
Material deformation 3
Migration of device or device component 3
Peeled 3
Fracture 3
Material fragmentation 3
Fire 3
Incorrect display 3
Crack 3
Failure to advance 3
Loss of or failure to bond 2
Contamination during use 2
Difficult to insert 2
Device emits odor 2
Overheating of device or device component 2
Material Protrusion 2
No Information 2
Device packaging compromised 2
Device displays error message 2
Improper or incorrect procedure or method 2
Invalid sensing 2
Component missing 1
Tear, rip or hole in device packaging 1
Failure to calibrate 1
Smoking 1
Sticking 1
Inaccurate synchronization 1
Unraveled material 1
Malposition of device 1
Ambient noise issue 1
Communication or transmission issue 1
Device or device fragments location unknown 1
Device-device incompatibility 1
Device markings issue 1
Electrical shorting 1
Human-Device Interface Issue 1
Mechanical jam 1
Incompatibility problem 1
Delivered as unsterile product 1
Occlusion within device 1
Difficult to position 1
Leak 1
Loose or intermittent connection 1
Hole in material 1
Image resolution poor 1
Circuit Failure 1
Coiled 1
Artifact 1
Bent 1
Electrical issue 1
False negative result 1
Difficult to flush 1
Total Device Problems 848

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 4 1 1
Class III 0 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Aug-31-2015
2 Arrow International Inc III Jan-29-2015
3 Biosense Webster, Inc. II Oct-01-2015
4 VasoNova, Inc. II Apr-09-2015
5 Volcano Corporation II Apr-10-2017
6 Volcano Corporation II May-25-2016
7 Volcano Corporation II Jun-25-2015

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