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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
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 380 380

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 511 877
Detachment of Device or Device Component 445 445
Poor Quality Image 395 395
Entrapment of Device 378 744
Material Twisted/Bent 183 183
Fracture 181 181
Material Integrity Problem 172 172
Material Deformation 157 279
Failure to Advance 109 109
Material Separation 100 832
Patient Device Interaction Problem 82 82
Contamination /Decontamination Problem 73 73
Physical Resistance/Sticking 61 61
No Display/Image 52 174
Unable to Obtain Readings 34 34
Break 27 27
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Material Perforation 23 23
Device Displays Incorrect Message 22 22
Leak/Splash 21 21
Difficult to Remove 19 263
Display or Visual Feedback Problem 18 18
Connection Problem 17 17
Difficult to Flush 16 16
Contamination 16 16
Retraction Problem 15 15
Difficult to Advance 15 15
Defective Device 15 15
Communication or Transmission Problem 14 14
Output Problem 13 13
Device Sensing Problem 11 11
Device-Device Incompatibility 9 9
Device Contamination with Chemical or Other Material 9 9
Therapeutic or Diagnostic Output Failure 9 9
Insufficient Information 9 9
Activation, Positioning or Separation Problem 9 9
Tear, Rip or Hole in Device Packaging 9 9
Difficult to Insert 9 9
Material Puncture/Hole 9 9
Delivered as Unsterile Product 8 8
Sharp Edges 8 8
Unsealed Device Packaging 7 7
Component Missing 6 6
Protective Measures Problem 6 6
Packaging Problem 6 6
Positioning Problem 6 6
Material Protrusion/Extrusion 6 6
Noise, Audible 5 5
Image Display Error/Artifact 5 5
Degraded 4 4
Material Frayed 4 4
Incorrect Interpretation of Signal 4 4
Stretched 4 4
Mechanical Jam 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Split, Cut or Torn 3 3
Poor Visibility 3 3
Improper or Incorrect Procedure or Method 3 3
Malposition of Device 3 3
Mechanical Problem 3 3
Failure to Power Up 3 3
Device Difficult to Setup or Prepare 2 2
Product Quality Problem 2 2
Loss of Power 2 2
Energy Output Problem 2 2
Material Fragmentation 2 246
Flaked 2 2
Computer Software Problem 2 2
Signal Artifact/Noise 2 2
Application Program Problem 2 2
Obstruction of Flow 2 2
Use of Device Problem 2 2
Device Damaged Prior to Use 2 2
Failure to Sense 2 2
Air/Gas in Device 2 2
Migration 2 2
Intermittent Loss of Power 1 1
Operating System Becomes Nonfunctional 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Dislodged or Dislocated 1 1
Problem with Software Installation 1 1
Failure to Reset 1 1
Material Too Rigid or Stiff 1 1
Defective Component 1 1
Unraveled Material 1 1
Failure to Unfold or Unwrap 1 1
Inadequacy of Device Shape and/or Size 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1621 2353
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 47 291
Cardiac Perforation 36 158
No Patient Involvement 26 26
Air Embolism 26 26
Non specific EKG/ECG Changes 23 23
Cardiac Arrest 22 22
Vascular Dissection 22 144
No Code Available 20 20
Pericardial Effusion 17 17
Death 14 14
Perforation of Vessels 13 257
Thrombosis/Thrombus 13 13
Obstruction/Occlusion 11 11
Ventricular Fibrillation 10 10
Chest Pain 9 9
Perforation 8 8
Arrhythmia 8 8
Bradycardia 8 8
Low Blood Pressure/ Hypotension 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
Hemorrhage/Bleeding 4 4
Hematoma 3 3
Pulmonary Edema 3 3
Atrial Perforation 3 3
Embolism/Embolus 3 3
Pain 3 3
Ischemic Heart Disease 2 2
Blood Loss 2 2
Diminished Pulse Pressure 2 2
Cardiogenic Shock 2 2
Stenosis 2 2
Pericarditis 2 2
ST Segment Elevation 2 2
Internal Organ Perforation 2 2
Great Vessel Perforation 2 2
Rupture 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
Intimal Dissection 1 123
Dyspnea 1 1
Cardiopulmonary Arrest 1 1
Itching Sensation 1 1
Hypersensitivity/Allergic reaction 1 1
Thrombosis 1 1
Transient Ischemic Attack 1 1
Ventricular Tachycardia 1 1
Necrosis 1 1
Swelling 1 1
Pleural Effusion 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Unspecified Respiratory Problem 1 1
Skin Inflammation/ Irritation 1 1
Unintended Radiation Exposure 1 1
Foreign Body Embolism 1 1
No Information 1 1
Discomfort 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Complete Heart Block 1 1
Thromboembolism 1 1
Pseudoaneurysm 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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