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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 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MEDINOL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIL LIFE SCIENCES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
NATEC MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
OSTIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material Rupture 3609
Balloon 2446
Break 995
Shaft 699
Failure to Advance 670
Catheter 557
Difficult to Remove 489
Deflation Problem 347
Material Separation 317
Adverse Event Without Identified Device or Use Problem 312
Burst Container or Vessel 270
Improper or Incorrect Procedure or Method 243
Inflation Problem 226
Difficult to Advance 226
Leak / Splash 196
Entrapment of Device 155
Detachment of Device or device Component 137
Material Deformation 128
Detachment Of Device Component 122
Kinked 82
Device Damaged Prior to Use 71
Deformation Due to Compressive Stress 71
Hole In Material 46
Device Contamination with Chemical or Other Material 34
Tip 32
Difficult to Open or Remove Packaging Material 30
Fracture 28
Failure to Fold 27
Material Split, Cut or Torn 27
Device Markings / Labelling Problem 26
Difficult To Position 24
Off-Label Use 23
Material Puncture / Hole 23
Stretched 22
Material Integrity Problem 21
Unsealed Device Packaging 20
Physical Resistance / Sticking 18
Defective Device 17
Device Damaged by Another Device 16
Physical Resistance 15
Material Perforation 15
Difficult to Insert 13
Torn Material 13
Device Handling Problem 11
Use of Device Problem 11
Device Issue 10
Positioning Problem 10
Physical Property Issue 9
Activation, Positioning or Separation Problem 9
Loose or Intermittent Connection 9
Product Quality Problem 8
Bent 8
Sticking 7
Unintended System Motion 6
Label 6
Device Expiration Issue 6
Device Dislodged or Dislocated 6
Contamination / decontamination Problem 6
Fluid Leak 5
Mechanical Problem 5
Contamination During Use 5
Device Slipped 5
Peeled / Delaminated 5
Incorrect Measurement 4
Component Missing 4
Component or Accessory Incompatibility 4
Device Operational Issue 4
Packaging Problem 4
Insufficient Information 4
Patient-Device Incompatibility 3
Device Packaging Compromised 3
Tear, Rip or Hole in Device Packaging 3
Defective Component 3
Retraction Problem 3
Hub 3
Seal 2
Guidewire 2
Protector 2
Stent 2
Difficult or Delayed Positioning 2
Inadequacy of Device Shape and/or Size 2
Device Contamination with Body Fluid 2
Device-Device Incompatibility 2
Folded 2
Device Misassembled During Manufacturing / Shipping 2
Device Operates Differently Than Expected 2
Material Distortion 2
Device Contaminated during manufacture or shipping 2
Material Protrusion / Extrusion 2
Material Twisted / Bent 2
Human Factors Issue 2
Noise, Audible 2
Material Too Soft / Flexible 2
Component Misassembled 1
Human-Device Interface Problem 1
Compatibility Problem 1
Incorrect Device Or Component Shipped 1
Mechanical Jam 1
Scratched Material 1
Delamination 1
Total Device Problems 13090

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I Feb-14-2020
2 Abbott Vascular I May-12-2017
3 Boston Scientific Corporation II Nov-26-2019
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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