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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheters, transluminal coronary angioplasty, percutaneous
Regulation Description Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
Definition A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Product CodeLOX
Regulation Number 870.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN INTERVENTIONAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
BROSMED MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MEDINOL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIL LIFE SCIENCES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
NATEC MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
OSTIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material Rupture 3352
Balloon 2450
Break 938
Shaft 702
Failure to Advance 654
Catheter 561
Difficult to Remove 438
Deflation Problem 303
Adverse Event Without Identified Device or Use Problem 279
Material Separation 269
Burst Container or Vessel 259
Improper or Incorrect Procedure or Method 222
Inflation Problem 206
Difficult to Advance 183
Leak / Splash 176
Entrapment of Device 148
Detachment of Device or device Component 128
Detachment Of Device Component 126
Material Deformation 109
Kinked 83
Device Damaged Prior to Use 72
Deformation Due to Compressive Stress 68
Hole In Material 47
Device Contamination with Chemical or Other Material 34
Tip 33
Difficult to Open or Remove Packaging Material 29
Fracture 27
Difficult To Position 24
Material Puncture / Hole 23
Material Integrity Problem 22
Device Markings / Labelling Problem 22
Material Split, Cut or Torn 21
Failure to Fold 18
Unsealed Device Packaging 18
Off-Label Use 18
Physical Resistance / Sticking 18
Defective Device 17
Device Damaged by Another Device 16
Physical Resistance 15
Stretched 15
Material Perforation 15
Torn Material 13
Device Handling Problem 13
Difficult to Insert 12
Activation, Positioning or Separation Problem 10
Use of Device Problem 10
Device Issue 10
Positioning Problem 10
Physical Property Issue 9
Bent 8
Loose or Intermittent Connection 8
Sticking 7
Device Expiration Issue 6
Device Dislodged or Dislocated 6
Product Quality Problem 6
Label 6
Device Slipped 5
Contamination / decontamination Problem 5
Contamination During Use 5
Peeled / Delaminated 5
Mechanical Problem 5
Unintended System Motion 5
Insufficient Information 4
Fluid Leak 4
Packaging Problem 4
Incorrect Measurement 4
Component or Accessory Incompatibility 4
Device Operational Issue 4
Component Missing 4
Device Packaging Compromised 3
Stent 3
Defective Component 3
Patient-Device Incompatibility 3
Device-Device Incompatibility 3
Retraction Problem 3
Hub 3
Tear, Rip or Hole in Device Packaging 3
Inadequacy of Device Shape and/or Size 3
Protector 2
Human Factors Issue 2
Device Operates Differently Than Expected 2
Material Twisted / Bent 2
Guidewire 2
Difficult or Delayed Positioning 2
Material Too Soft / Flexible 2
Nonstandard device 2
Material Distortion 2
Material Protrusion / Extrusion 2
Device Misassembled During Manufacturing / Shipping 2
Seal 2
Device Contamination with Body Fluid 2
Folded 2
Biofilm coating in Device 1
Positioning Failure 1
Device Difficult to Setup or Prepare 1
Incorrect Device Or Component Shipped 1
Stylet 1
IOL (Intraocular Lens) Implant 1
Explanted 1
Material Fragmentation 1
Total Device Problems 12413

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I May-12-2017
2 Cordis Corporation II Aug-28-2014
3 Cordis Corporation II Jun-11-2014
4 Medtronic Vascular Galway DBA Medtronic Ireland II Oct-11-2019
5 Medtronic Vascular Galway DBA Medtronic Ireland II Sep-20-2017

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