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

MDR Year MDR Reports MDR Events
2020 288 1142
2021 353 1573
2022 473 473
2023 697 697
2024 1155 1155
2025 281 281

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 898 1264
Poor Quality Image 618 618
Entrapment of Device 546 912
Detachment of Device or Device Component 511 511
Material Twisted/Bent 296 296
Material Integrity Problem 263 263
Fracture 258 258
Material Deformation 239 361
Failure to Advance 159 159
Material Separation 102 834
Physical Resistance/Sticking 102 102
Patient Device Interaction Problem 100 100
Contamination /Decontamination Problem 76 76
No Display/Image 58 180
Unable to Obtain Readings 52 52
Connection Problem 36 36
Break 28 28
Display or Visual Feedback Problem 27 27
Difficult to Flush 27 27
Device Displays Incorrect Message 27 27
Leak/Splash 26 26
Material Perforation 25 25
Difficult to Advance 23 23
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Retraction Problem 22 22
Difficult to Remove 20 264
Contamination 17 17
Communication or Transmission Problem 16 16
Defective Device 15 15
Device-Device Incompatibility 14 14
Mechanical Jam 14 14
Device Contamination with Chemical or Other Material 13 13
Output Problem 12 12
Activation, Positioning or Separation Problem 12 12
Material Puncture/Hole 12 12
Tear, Rip or Hole in Device Packaging 11 11
Device Sensing Problem 10 10
Therapeutic or Diagnostic Output Failure 10 10
Positioning Problem 10 10
Insufficient Information 9 9
Difficult to Insert 9 9
Mechanical Problem 9 9
Packaging Problem 9 9
Component Missing 8 8
Noise, Audible 8 8
Image Display Error/Artifact 7 7
Delivered as Unsterile Product 7 7
Unsealed Device Packaging 6 6
Failure to Power Up 6 6
Sharp Edges 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2594 3326
No Consequences Or Impact To Patient 172 172
Cardiac Tamponade 78 78
Insufficient Information 75 75
Foreign Body In Patient 67 311
No Known Impact Or Consequence To Patient 46 534
Cardiac Perforation 38 160
Air Embolism 35 35
Non specific EKG/ECG Changes 34 34
Cardiac Arrest 26 26
Vascular Dissection 23 145
Obstruction/Occlusion 17 17
Thrombosis/Thrombus 17 17
Chest Pain 15 15
No Patient Involvement 15 15
Pericardial Effusion 14 14
Perforation of Vessels 14 258
Arrhythmia 10 10
No Code Available 10 10
Myocardial Infarction 10 10
Ventricular Fibrillation 10 10
Perforation 8 8
Bradycardia 8 8
Low Blood Pressure/ Hypotension 7 7
Tachycardia 7 7
Complaint, Ill-Defined 6 6
Embolism/Embolus 6 6
Death 5 5
Heart Block 5 5
Hemorrhage/Bleeding 4 4
Ischemia 4 4
Unspecified Tissue Injury 4 4
Device Embedded In Tissue or Plaque 3 3
Pseudoaneurysm 3 3
Great Vessel Perforation 3 3
Hematoma 3 3
Ischemic Heart Disease 3 3
Pulmonary Edema 3 3
Restenosis 2 2
Stenosis 2 2
Cardiogenic Shock 2 2
Pericarditis 2 2
Rupture 2 2
Diminished Pulse Pressure 2 2
Failure of Implant 2 2
Stroke/CVA 2 2
Needle Stick/Puncture 1 1
Pleural Effusion 1 1
Thrombosis 1 1
Discomfort 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 Conavi Medical Inc. I Apr-23-2025
5 Siemens Medical Solutions USA, Inc. II Oct-08-2020
6 Volcano Corp III Jun-29-2022
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