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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device catheter, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ARRAVASC LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 3
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTEGO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 6
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NATEC MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 3
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
O'CONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Balloon 3029
Material Rupture 2872
Burst Container or Vessel 1454
Adverse Event Without Identified Device or Use Problem 417
Leak / Splash 407
Detachment of Device or device Component 340
Catheter 293
Difficult to Remove 280
Deflation Problem 253
Break 228
Retraction Problem 183
Detachment Of Device Component 157
Inflation Problem 131
Material Separation 115
Entrapment of Device 93
Shaft 93
Failure to Advance 91
Material Deformation 84
Difficult to Advance 59
Material Frayed 56
Cutter 55
Improper or Incorrect Procedure or Method 50
Tip 47
Hole In Material 40
Peeled / Delaminated 39
Device Handling Problem 34
Material Puncture / Hole 34
Device Dislodged or Dislocated 27
Torn Material 26
Use of Device Problem 24
Fluid Leak 22
Defective Device 21
Device-Device Incompatibility 21
Device Contamination with Chemical or Other Material 21
Off-Label Use 20
Packaging Problem 19
Crack 19
Device Markings / Labelling Problem 18
Structural Problem 18
Unraveled Material 17
Fracture 17
Difficult to Insert 16
Kinked 15
Device Damaged Prior to Use 15
Material Integrity Problem 15
Material Split, Cut or Torn 14
Material Twisted / Bent 13
Device Damaged by Another Device 13
Difficult To Position 10
Unsealed Device Packaging 9
Partial Blockage 8
Indicator 8
Device Operates Differently Than Expected 8
Physical Resistance 7
Bent 7
Material Fragmentation 7
Tear, Rip or Hole in Device Packaging 6
Balloon rupture 6
Failure to Fold 6
Component Missing 5
Deformation Due to Compressive Stress 5
Appropriate Term/Code Not Available 5
Stretched 5
Device Expiration Issue 4
Device Packaging Compromised 4
Occlusion Within Device 4
Delivered as Unsterile Product 3
Stent 3
Defective Component 3
Physical Resistance / Sticking 3
Shelf Life Exceeded 3
Hub 3
Flaked 2
Device Disinfection Or Sterilization Issue 2
Filter 2
Material Perforation 2
Display 2
Unintended Movement 2
Sticking 2
Folded 2
Contamination During Use 2
Product Quality Problem 2
Device Difficult to Setup or Prepare 2
Activation, Positioning or Separation Problem 2
Difficult or Delayed Positioning 2
Wire 2
Contamination / decontamination Problem 2
Connection Problem 2
Activation Failure Including Expansion Failures 2
Component Misassembled 2
Unintended System Motion 1
Protector 1
Coiled 1
No Apparent Adverse Event 1
Obstruction of Flow 1
Balloon burst 1
Loss of or Failure to Bond 1
Difficult to Flush 1
Incorrect Measurement 1
Y-Piece Connector 1
Total Device Problems 11503

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Feb-11-2014
2 BrosMed Medical Co.,Ltd. II Feb-27-2019
3 Cordis Corporation II Nov-06-2018
4 Cordis Corporation II Jan-16-2015
5 EXP Pharmaceutical Services Corp II Jul-24-2015
6 Medtronic Inc II Dec-22-2016
7 Us Endovascular II Apr-11-2016
8 ev3, Inc. II Apr-22-2016

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