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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
  1.  K203726  ACUSON AcuNav Volume Intracardiac Echocardiography ...
  2.  K212959  ACUSON AcuNav Volume Intracardiac Echocardiography ...
  3.  K233270  AcuNav Crystal Ultrasound Catheter

MDR Year MDR Reports MDR Events
2019 237 237
2020 288 1142
2021 353 1573
2022 473 473
2023 697 697
2024 709 709

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 708 1074
Poor Quality Image 510 510
Detachment of Device or Device Component 498 498
Entrapment of Device 426 792
Material Twisted/Bent 217 217
Material Integrity Problem 206 206
Fracture 195 195
Material Deformation 194 316
Failure to Advance 130 130
Material Separation 103 835
Patient Device Interaction Problem 86 86
Physical Resistance/Sticking 75 75
Contamination /Decontamination Problem 75 75
No Display/Image 52 174
Unable to Obtain Readings 44 44
Break 29 29
Device Displays Incorrect Message 25 25
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Material Perforation 23 23
Leak/Splash 23 23
Difficult to Flush 20 20
Difficult to Remove 20 264
Retraction Problem 19 19
Display or Visual Feedback Problem 19 19
Connection Problem 18 18
Contamination 18 18
Difficult to Advance 16 16
Defective Device 15 15
Output Problem 14 14
Communication or Transmission Problem 14 14
Device Sensing Problem 11 11
Activation, Positioning or Separation Problem 11 11
Difficult to Insert 10 10
Device Contamination with Chemical or Other Material 10 10
Device-Device Incompatibility 10 10
Insufficient Information 9 9
Therapeutic or Diagnostic Output Failure 9 9
Material Puncture/Hole 9 9
Tear, Rip or Hole in Device Packaging 9 9
Delivered as Unsterile Product 8 8
Sharp Edges 8 8
Positioning Problem 7 7
Unsealed Device Packaging 7 7
Material Protrusion/Extrusion 6 6
Protective Measures Problem 6 6
Packaging Problem 6 6
Component Missing 6 6
Noise, Audible 5 5
Image Display Error/Artifact 5 5
Incorrect Interpretation of Signal 4 4
Mechanical Jam 4 4
Stretched 4 4
Mechanical Problem 4 4
Degraded 4 4
Material Frayed 4 4
Failure to Sense 4 4
Improper or Incorrect Procedure or Method 3 3
Poor Visibility 3 3
Material Split, Cut or Torn 3 3
Malposition of Device 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Application Program Problem 3 3
Failure to Power Up 3 3
Loss of Power 2 2
Material Fragmentation 2 246
Air/Gas in Device 2 2
Flaked 2 2
Computer Software Problem 2 2
Device Damaged Prior to Use 2 2
Device Markings/Labelling Problem 2 2
No Apparent Adverse Event 2 2
Device Difficult to Setup or Prepare 2 2
Signal Artifact/Noise 2 2
Use of Device Problem 2 2
Obstruction of Flow 2 2
Product Quality Problem 2 2
Migration 2 2
Energy Output Problem 2 2
Defective Component 1 1
Migration or Expulsion of Device 1 1
Problem with Software Installation 1 1
Operating System Becomes Nonfunctional 1 1
Deformation Due to Compressive Stress 1 1
Appropriate Term/Code Not Available 1 1
Incorrect Measurement 1 1
Device Dislodged or Dislocated 1 1
Unraveled Material 1 1
Failure to Reset 1 1
Erratic or Intermittent Display 1 1
Loose or Intermittent Connection 1 1
Device Alarm System 1 1
Imprecision 1 1
Crack 1 1
Overheating of Device 1 1
Nonstandard Device 1 1
Failure to Align 1 1
Failure to Unfold or Unwrap 1 1
Device Contaminated During Manufacture or Shipping 1 1
Inadequacy of Device Shape and/or Size 1 1
Incomplete or Missing Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1927 2659
No Consequences Or Impact To Patient 302 302
No Known Impact Or Consequence To Patient 95 583
Cardiac Tamponade 92 92
Insufficient Information 67 67
Foreign Body In Patient 53 297
Cardiac Perforation 36 158
Air Embolism 33 33
Non specific EKG/ECG Changes 27 27
No Patient Involvement 26 26
Vascular Dissection 22 144
Cardiac Arrest 22 22
No Code Available 20 20
Pericardial Effusion 18 18
Thrombosis/Thrombus 15 15
Obstruction/Occlusion 15 15
Death 14 14
Chest Pain 13 13
Perforation of Vessels 13 257
Ventricular Fibrillation 10 10
Bradycardia 9 9
Arrhythmia 8 8
Low Blood Pressure/ Hypotension 8 8
Perforation 8 8
Myocardial Infarction 7 7
Tachycardia 7 7
Complaint, Ill-Defined 7 7
Device Embedded In Tissue or Plaque 5 5
Heart Block 4 4
Unspecified Tissue Injury 4 4
Hematoma 4 4
Hemorrhage/Bleeding 4 4
Pain 3 3
Pulmonary Edema 3 3
Great Vessel Perforation 3 3
Embolism/Embolus 3 3
Atrial Perforation 3 3
Ischemic Heart Disease 2 2
Blood Loss 2 2
Diminished Pulse Pressure 2 2
Rupture 2 2
Cardiogenic Shock 2 2
Stenosis 2 2
Pericarditis 2 2
ST Segment Elevation 2 2
Internal Organ Perforation 2 2
Failure of Implant 2 2
Ischemia 2 2
Stroke/CVA 2 2
Restenosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cardiopulmonary Arrest 1 1
Atrial Flutter 1 1
Intimal Dissection 1 123
Itching Sensation 1 1
Dyspnea 1 1
Cardiac Enzyme Elevation 1 1
Pleural Effusion 1 1
Hypersensitivity/Allergic reaction 1 1
Necrosis 1 1
Swelling 1 1
Thrombosis 1 1
Transient Ischemic Attack 1 1
Ventricular Tachycardia 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Unspecified Respiratory Problem 1 1
Skin Inflammation/ Irritation 1 1
Unintended Radiation Exposure 1 1
Thromboembolism 1 1
Foreign Body Embolism 1 1
No Information 1 1
Discomfort 1 1
Injury 1 1
Complete Heart Block 1 1
Pseudoaneurysm 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1

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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