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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 1
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 602 602

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 649 1015
Detachment of Device or Device Component 487 487
Poor Quality Image 472 472
Entrapment of Device 413 779
Material Twisted/Bent 208 208
Material Integrity Problem 196 196
Fracture 189 189
Material Deformation 186 308
Failure to Advance 123 123
Material Separation 102 834
Patient Device Interaction Problem 84 84
Contamination /Decontamination Problem 75 75
Physical Resistance/Sticking 72 72
No Display/Image 52 174
Unable to Obtain Readings 38 38
Break 28 28
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 Remove 20 264
Retraction Problem 19 19
Display or Visual Feedback Problem 19 19
Contamination 18 18
Connection Problem 18 18
Difficult to Flush 17 17
Difficult to Advance 16 16
Defective Device 15 15
Output Problem 14 14
Communication or Transmission Problem 14 14
Device Sensing Problem 11 11
Device-Device Incompatibility 10 10
Device Contamination with Chemical or Other Material 10 10
Activation, Positioning or Separation Problem 10 10
Difficult to Insert 10 10
Tear, Rip or Hole in Device Packaging 9 9
Material Puncture/Hole 9 9
Therapeutic or Diagnostic Output Failure 9 9
Insufficient Information 9 9
Sharp Edges 8 8
Delivered as Unsterile Product 8 8
Unsealed Device Packaging 7 7
Positioning Problem 7 7
Protective Measures Problem 6 6
Packaging Problem 6 6
Material Protrusion/Extrusion 6 6
Component Missing 6 6
Image Display Error/Artifact 5 5
Noise, Audible 5 5
Mechanical Jam 4 4
Material Frayed 4 4
Degraded 4 4
Failure to Sense 4 4
Incorrect Interpretation of Signal 4 4
Stretched 4 4
Improper or Incorrect Procedure or Method 3 3
Malposition of Device 3 3
Application Program Problem 3 3
Mechanical Problem 3 3
Failure to Power Up 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Split, Cut or Torn 3 3
Poor Visibility 3 3
Air/Gas in Device 2 2
Migration 2 2
No Apparent Adverse Event 2 2
Device Difficult to Setup or Prepare 2 2
Product Quality Problem 2 2
Loss of Power 2 2
Energy Output Problem 2 2
Computer Software Problem 2 2
Signal Artifact/Noise 2 2
Material Fragmentation 2 246
Flaked 2 2
Obstruction of Flow 2 2
Use of Device Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 1 1
Unraveled Material 1 1
Failure to Unfold or Unwrap 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Too Rigid or Stiff 1 1
Failure to Reset 1 1
Failure to Align 1 1
Incomplete or Missing Packaging 1 1
Deformation Due to Compressive Stress 1 1
Device Damaged by Another Device 1 1
Computer Operating System Problem 1 1
Separation Failure 1 1
Device Alarm System 1 1
Erratic or Intermittent Display 1 1
Crack 1 1
Overheating of Device 1 1
Off-Label Use 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Imprecision 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1828 2560
No Consequences Or Impact To Patient 302 302
No Known Impact Or Consequence To Patient 95 583
Cardiac Tamponade 91 91
Insufficient Information 64 64
Foreign Body In Patient 52 296
Cardiac Perforation 36 158
Air Embolism 32 32
Non specific EKG/ECG Changes 26 26
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
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
Great Vessel Perforation 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
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
Ventricular Tachycardia 1 1
Swelling 1 1
Thrombosis 1 1
Transient Ischemic Attack 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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