• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device syringe, balloon inflation
Product CodeMAV
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 246 246
2018 300 300
2019 199 199
2020 101 101
2021 186 186
2022 402 402

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 633 633
Loose or Intermittent Connection 167 167
Display or Visual Feedback Problem 131 131
Device Packaging Compromised 109 109
Inaccurate Information 108 108
Break 105 105
Device Contamination with Chemical or Other Material 71 71
Incorrect Measurement 54 54
Tear, Rip or Hole in Device Packaging 40 40
Incorrect, Inadequate or Imprecise Resultor Readings 36 36
Material Separation 17 17
Packaging Problem 17 17
Physical Resistance/Sticking 16 16
Device Damaged Prior to Use 12 12
Improper Device Output 12 12
Inflation Problem 11 11
Appropriate Term/Code Not Available 10 10
Pressure Problem 10 10
Deflation Problem 9 9
Crack 8 8
Detachment Of Device Component 6 6
Unsealed Device Packaging 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Noise, Audible 6 6
Device Contaminated During Manufacture or Shipping 6 6
Detachment of Device or Device Component 6 6
Improper or Incorrect Procedure or Method 6 6
Suction Problem 5 5
Defective Device 5 5
Material Puncture/Hole 5 5
Product Quality Problem 5 5
Mechanical Problem 5 5
Fluid Leak 4 4
Fitting Problem 4 4
Insufficient Information 4 4
Device Operates Differently Than Expected 3 3
Contamination /Decontamination Problem 3 3
Difficult to Remove 3 3
Misconnection 3 3
Material Rupture 2 2
Failure to Zero 2 2
Difficult To Position 2 2
Decrease in Pressure 2 2
Increase in Pressure 2 2
Material Integrity Problem 2 2
No Pressure 2 2
Output Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Split, Cut or Torn 1 1
Mechanical Jam 1 1
Connection Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Issue 1 1
Device Displays Incorrect Message 1 1
Calibration Problem 1 1
Fracture 1 1
Difficult to Insert 1 1
Unable to Obtain Readings 1 1
Retraction Problem 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1
No Device Output 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Air Leak 1 1
Display Difficult to Read 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 571 571
No Consequences Or Impact To Patient 479 479
No Patient Involvement 294 294
No Known Impact Or Consequence To Patient 54 54
Insufficient Information 11 11
Vascular Dissection 6 6
Air Embolism 5 5
No Information 4 4
Death 4 4
Bradycardia 3 3
Cardiac Arrest 3 3
Low Blood Pressure/ Hypotension 3 3
Angina 2 2
Arrhythmia 2 2
Cardiogenic Shock 2 2
Hemorrhage/Bleeding 1 1
No Code Available 1 1
Missing Value Reason 1 1
Thrombosis/Thrombus 1 1
Cerebrospinal Fluid Leakage 1 1
Laceration(s) 1 1
Perforation 1 1
Sepsis 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Apr-13-2022
2 Abbott Vascular II Feb-27-2019
3 Boston Scientific Corporation II Aug-16-2017
4 DeRoyal Industries Inc II Jun-29-2017
5 PEROUSE MEDICAL II Apr-28-2017
6 Vascular Solutions, Inc. II May-31-2017
-
-