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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 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 453 1185
Fracture 194 194
Material Separation 142 142
Break 110 232
Difficult to Remove 108 108
Physical Resistance/Sticking 100 222
Detachment of Device or Device Component 94 94
Device-Device Incompatibility 74 74
Device Contamination with Chemical or Other Material 66 66
Material Deformation 45 45
Detachment Of Device Component 42 42
Difficult to Advance 40 40
Entrapment of Device 38 38
Defective Device 34 34
Material Integrity Problem 25 25
Insufficient Information 20 20
Mechanical Jam 19 385
Positioning Problem 16 16
Crack 16 16
Material Fragmentation 15 15
Difficult to Insert 14 14
Failure to Advance 14 14
Unraveled Material 14 14
Appropriate Term/Code Not Available 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Device Operates Differently Than Expected 12 12
Sharp Edges 12 12
Material Frayed 12 12
Fluid/Blood Leak 10 10
Stretched 10 10
Deformation Due to Compressive Stress 10 10
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
Use of Device Problem 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
Migration 5 5
Leak/Splash 5 5
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
Noise, Audible 4 4
Device Contaminated During Manufacture or Shipping 4 4
Difficult to Open or Remove Packaging Material 4 4
Mechanics Altered 3 125
Device Slipped 3 3
Activation, Positioning or Separation Problem 3 3
Calcified 3 3
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
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
Patient Device Interaction Problem 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Activation Problem 1 1
Scratched Material 1 1
No Apparent Adverse Event 1 1
Activation Failure 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Naturally Worn 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 276 886
Foreign Body In Patient 194 316
No Consequences Or Impact To Patient 144 144
Pericardial Effusion 116 360
Low Blood Pressure/ Hypotension 104 104
No Known Impact Or Consequence To Patient 101 101
Perforation of Vessels 94 704
Great Vessel Perforation 85 329
Iatrogenic Source 59 181
Device Embedded In Tissue or Plaque 57 57
Cardiac Tamponade 55 55
Hemorrhage/Bleeding 51 51
Death 50 172
Thrombosis/Thrombus 47 47
Cardiac Perforation 45 45
No Code Available 40 40
Hematoma 27 27
Perforation 26 26
Vascular Dissection 21 21
Injury 20 20
Insufficient Information 19 19
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
Foreign body, removal of 9 9
Pseudoaneurysm 9 9
Arrhythmia 8 8
Air Embolism 7 7
Calcium Deposits/Calcification 7 7
No Information 7 7
Discomfort 7 7
Surgical procedure, additional 6 6
Pain 6 6
Pleural Effusion 5 5
Vasoconstriction 5 5
Tissue Damage 5 5
Non specific EKG/ECG Changes 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Asystole 4 4
Patient Problem/Medical Problem 4 4
Rupture 4 4
Intimal Dissection 4 4
Pulmonary Embolism 4 4
Ventricular Fibrillation 4 4
Pneumothorax 3 3
Hypoxia 3 3
Vessel Or Plaque, Device Embedded In 3 3
Hemostasis 3 3
Hemothorax 3 3
Fistula 3 3
Thrombosis 3 3
Nonresorbable materials, unretrieved in body 3 3
Respiratory Failure 3 3
Thromboembolism 3 3
Cusp Tear 2 2
Blood pressure, decreased 2 2
Fibrosis 2 2
Electric Shock 2 2
Obstruction/Occlusion 2 2
Heart Block 2 2
Respiratory Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body Embolism 2 2
Foreign Body Reaction 2 2
High Blood Pressure/ Hypertension 2 2
Dyspnea 2 2
Embolus 2 2
Endocarditis 2 2
Chest Pain 2 2
Scarring 2 2
Sepsis 2 2
Tricuspid Regurgitation 2 2
Ischemia 2 2
Tachycardia 2 2
Excessive Tear Production 2 2
Hypovolemia 1 1
Peritonitis 1 1
Stenosis 1 1
Hot Flashes/Flushes 1 1
Tingling 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Heart Failure 1 1
Vomiting 1 1
Shock 1 1
Renal Failure 1 1
Scar Tissue 1 1
Pneumonia 1 1
Peripheral Vascular Disease 1 1
Failure of Implant 1 1
Inflammation 1 1
Paralysis 1 1
Myocardial Infarction 1 1
Internal Organ Perforation 1 1
Aortic Regurgitation 1 1
Cardiomyopathy 1 1
Cardiopulmonary Arrest 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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