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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, vessel, for percutaneous catheterization
Product CodeDRE
Regulation Number 870.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
ARSTASIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOTEQUE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDIACASSIST INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
COOK VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC.
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MC3 INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP ( MEDICAL COMPONENTS)
  SUBSTANTIALLY EQUIVALENT 1
MEDRON, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SUMMIT ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ULTRASONIX MEDICAL CORPATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XCARDIA INNOVATION LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 80 80
2015 82 82
2016 84 84
2017 101 101
2018 126 126
2019 144 144
2020 120 120
2021 115 1579
2022 136 136
2023 392 392
2024 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 476 1208
Fracture 199 199
Material Separation 146 146
Break 112 234
Difficult to Remove 109 109
Detachment of Device or Device Component 103 103
Physical Resistance/Sticking 102 224
Device-Device Incompatibility 77 77
Device Contamination with Chemical or Other Material 66 66
Material Deformation 48 48
Difficult to Advance 45 45
Detachment Of Device Component 42 42
Entrapment of Device 39 39
Defective Device 34 34
Positioning Problem 28 28
Material Integrity Problem 26 26
Insufficient Information 20 20
Mechanical Jam 19 385
Crack 16 16
Material Fragmentation 16 16
Difficult to Insert 15 15
Unraveled Material 15 15
Failure to Advance 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Appropriate Term/Code Not Available 14 14
Material Frayed 13 13
Sharp Edges 12 12
Device Operates Differently Than Expected 12 12
Fluid/Blood Leak 10 10
Deformation Due to Compressive Stress 10 10
Stretched 10 10
Use of Device Problem 9 9
Component or Accessory Incompatibility 9 9
Migration or Expulsion of Device 9 9
Device Damaged by Another Device 9 9
Device Dislodged or Dislocated 8 8
Torn Material 8 8
Packaging Problem 8 8
Sticking 8 8
Retraction Problem 8 8
Failure to Cut 7 129
Loss of or Failure to Bond 7 7
Material Twisted/Bent 7 7
Material Split, Cut or Torn 7 7
Leak/Splash 6 6
Migration 5 5
Noise, Audible 4 4
Device Contaminated During Manufacture or Shipping 4 4
Difficult to Open or Remove Packaging Material 4 4
Unsealed Device Packaging 4 4
Partial Blockage 4 4
Split 4 4
Failure to Align 4 4
Cut In Material 4 4
Component Missing 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Puncture/Hole 4 4
Flaked 4 4
Other (for use when an appropriate device code cannot be identified) 4 4
Device Slipped 3 3
Activation, Positioning or Separation Problem 3 3
Calcified 3 3
Mechanics Altered 3 125
Material Protrusion/Extrusion 2 2
Human-Device Interface Problem 2 2
Device Markings/Labelling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Separation Problem 2 2
Component Falling 2 2
Disconnection 2 2
Material Disintegration 2 2
Peeled/Delaminated 2 2
Occlusion Within Device 2 2
Nonstandard Device 2 2
Kinked 2 2
Physical Resistance 2 2
Tip breakage 2 2
Uncoiled 1 1
Device Inoperable 1 1
Material Perforation 1 1
Fitting Problem 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Separation Failure 1 1
Device Or Device Fragments Location Unknown 1 1
Obstruction of Flow 1 1
Wire(s), breakage of 1 1
Structural Problem 1 1
Lead(s), breakage of 1 1
Delivered as Unsterile Product 1 1
Pacing Problem 1 1
Perivalvular Leak 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Membrane tear(s) 1 1
Hole In Material 1 1
Erratic or Intermittent Display 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 292 902
Foreign Body In Patient 199 321
No Consequences Or Impact To Patient 144 144
Pericardial Effusion 133 377
Low Blood Pressure/ Hypotension 119 119
No Known Impact Or Consequence To Patient 101 101
Perforation of Vessels 97 707
Great Vessel Perforation 91 335
Iatrogenic Source 59 181
Cardiac Tamponade 58 58
Device Embedded In Tissue or Plaque 57 57
Cardiac Perforation 52 52
Hemorrhage/Bleeding 52 52
Death 50 172
Thrombosis/Thrombus 50 50
No Code Available 40 40
Hematoma 29 29
Perforation 27 27
Vascular Dissection 21 21
Injury 20 20
Insufficient Information 20 20
Laceration(s) 19 19
Embolism 18 18
No Patient Involvement 17 17
Blood Loss 13 13
Cardiac Arrest 13 13
Atrial Perforation 12 12
Unspecified Infection 11 11
Air Embolism 10 10
Arrhythmia 9 9
Foreign body, removal of 9 9
Pseudoaneurysm 9 9
No Information 7 7
Discomfort 7 7
Calcium Deposits/Calcification 7 7
Non specific EKG/ECG Changes 6 6
Pain 6 6
Pleural Effusion 6 6
Surgical procedure, additional 6 6
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Vasoconstriction 5 5
Tissue Damage 5 5
Ventricular Fibrillation 4 4
Hypoxia 4 4
Intimal Dissection 4 4
Pulmonary Embolism 4 4
Asystole 4 4
Patient Problem/Medical Problem 4 4
Rupture 4 4
Nonresorbable materials, unretrieved in body 3 3
Respiratory Failure 3 3
Thromboembolism 3 3
Heart Block 3 3
Vessel Or Plaque, Device Embedded In 3 3
Hemostasis 3 3
Hemothorax 3 3
Fistula 3 3
Foreign Body Reaction 3 3
Pneumothorax 3 3
Thrombosis 3 3
Sepsis 3 3
Ischemia 2 2
Scarring 2 2
Tachycardia 2 2
Tricuspid Regurgitation 2 2
Vomiting 2 2
High Blood Pressure/ Hypertension 2 2
Dyspnea 2 2
Embolus 2 2
Endocarditis 2 2
Chest Pain 2 2
Foreign Body Embolism 2 2
Respiratory Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Retroperitoneal Hemorrhage 2 2
Cusp Tear 2 2
Diminished Pulse Pressure 2 2
Blood pressure, decreased 2 2
Electric Shock 2 2
Fibrosis 2 2
Obstruction/Occlusion 2 2
Excessive Tear Production 2 2
Hypovolemia 1 1
Peritonitis 1 1
Stenosis 1 1
Loss of consciousness 1 1
Post Operative Wound Infection 1 1
Paraplegia 1 1
Diaphoresis 1 1
Low Oxygen Saturation 1 1
Vascular System (Circulation), Impaired 1 1
Skin Tears 1 1
Swelling/ Edema 1 1
Unspecified Respiratory Problem 1 1
Cough 1 1
Low White Blood Cell Count 1 1
Ruptured Aneurysm 1 1
Unspecified Vascular Problem 1 1
Aortic Regurgitation 1 1
Cardiomyopathy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Mar-21-2024
2 Argon Medical Devices, Inc II Aug-14-2020
3 Argon Medical Devices, Inc II Mar-01-2016
4 Argon Medical Devices, Inc II Jun-02-2010
5 Argon Medical Devices, Inc III Feb-02-2010
6 Boston Scientific Corporation II Nov-21-2011
7 Cardiac Assist, Inc II Apr-23-2021
8 Cordis Corporation II Jul-15-2021
9 Cordis Corporation II Mar-15-2016
10 Galt Medical Corp II May-11-2010
11 Galt Medical Corporation II Jul-27-2018
12 Maquet Cardiovascular Us Sales, Llc II Mar-27-2020
13 Merit Medical Systems, Inc. II Jun-22-2015
14 Merit Medical Systems, Inc. II Dec-14-2009
15 Procedure Products, Inc. II Dec-01-2015
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