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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
Definition For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Product CodeOBJ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
NORTHEAST SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS IMAGE GUIDED THERAPY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PROVISIO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 237 237
2020 288 1142
2021 353 1573
2022 473 473
2023 697 697
2024 874 874

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 766 1132
Poor Quality Image 542 542
Detachment of Device or Device Component 514 514
Entrapment of Device 459 825
Material Twisted/Bent 236 236
Material Integrity Problem 224 224
Fracture 211 211
Material Deformation 205 327
Failure to Advance 142 142
Material Separation 105 837
Patient Device Interaction Problem 89 89
Physical Resistance/Sticking 79 79
Contamination /Decontamination Problem 77 77
No Display/Image 52 174
Unable to Obtain Readings 48 48
Break 30 30
Device Displays Incorrect Message 25 25
Material Perforation 25 25
Leak/Splash 25 25
Display or Visual Feedback Problem 24 24
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Difficult to Remove 21 265
Difficult to Flush 20 20
Retraction Problem 19 19
Connection Problem 18 18
Contamination 18 18
Difficult to Advance 17 17
Defective Device 16 16
Communication or Transmission Problem 15 15
Output Problem 14 14
Device Contamination with Chemical or Other Material 12 12
Device Sensing Problem 11 11
Activation, Positioning or Separation Problem 11 11
Difficult to Insert 11 11
Material Puncture/Hole 10 10
Device-Device Incompatibility 10 10
Tear, Rip or Hole in Device Packaging 10 10
Insufficient Information 9 9
Therapeutic or Diagnostic Output Failure 9 9
Delivered as Unsterile Product 9 9
Sharp Edges 8 8
Unsealed Device Packaging 7 7
Positioning Problem 7 7
Packaging Problem 7 7
Mechanical Problem 7 7
Noise, Audible 7 7
Component Missing 6 6
Material Protrusion/Extrusion 6 6
Protective Measures Problem 6 6
Image Display Error/Artifact 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2078 2810
No Consequences Or Impact To Patient 302 302
No Known Impact Or Consequence To Patient 95 583
Cardiac Tamponade 92 92
Insufficient Information 68 68
Foreign Body In Patient 58 302
Cardiac Perforation 40 162
Air Embolism 33 33
Non specific EKG/ECG Changes 31 31
No Patient Involvement 26 26
Vascular Dissection 22 144
Cardiac Arrest 22 22
No Code Available 20 20
Pericardial Effusion 18 18
Obstruction/Occlusion 15 15
Thrombosis/Thrombus 15 15
Death 14 14
Perforation of Vessels 13 257
Chest Pain 13 13
Ventricular Fibrillation 10 10
Arrhythmia 9 9
Bradycardia 9 9
Perforation 8 8
Low Blood Pressure/ Hypotension 8 8
Complaint, Ill-Defined 7 7
Tachycardia 7 7
Myocardial Infarction 7 7
Device Embedded In Tissue or Plaque 5 5
Unspecified Tissue Injury 4 4
Hematoma 4 4
Hemorrhage/Bleeding 4 4
Heart Block 4 4
Pulmonary Edema 3 3
Great Vessel Perforation 3 3
Pain 3 3
Atrial Perforation 3 3
Embolism/Embolus 3 3
Pericarditis 2 2
Internal Organ Perforation 2 2
ST Segment Elevation 2 2
Cardiogenic Shock 2 2
Blood Loss 2 2
Rupture 2 2
Diminished Pulse Pressure 2 2
Ischemic Heart Disease 2 2
Ischemia 2 2
Restenosis 2 2
Failure of Implant 2 2
Stroke/CVA 2 2
Stenosis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Acist Medical Systems I Mar-04-2021
2 Boston Scientific Corporation II Mar-28-2024
3 Boston Scientific Corporation II Oct-22-2020
4 Siemens Medical Solutions USA, Inc. II Oct-08-2020
5 Volcano Corp III Jun-29-2022
6 Volcano Corporation II Jan-11-2019
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