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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, percutaneous
Regulation Description Percutaneous catheter.
Product CodeDQY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED CATHETER THERAPIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASAHI
  SUBSTANTIALLY EQUIVALENT 9
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHERA, INC.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CRUZAR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CURATIVE MEDICAL TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON PROFESSIONALS, INC.
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 4
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 3
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ROXWOOD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
SEQUENT MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SEQUENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (ABBOTT LABORATORIES)
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
SUREFIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TNI MANUFACTURING, INC
  SUBSTANTIALLY EQUIVALENT 2
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Material Rupture 1938
Break 1350
Adverse Event Without Identified Device or Use Problem 875
Balloon 860
Kinked 777
Material Deformation 775
Leak / Splash 626
Detachment of Device or device Component 600
Catheter 572
Device Damaged Prior to Use 523
Failure to Advance 494
Retraction Problem 418
Material Separation 401
Physical Resistance 391
Detachment Of Device Component 357
Shaft 329
Unraveled Material 288
Peeled / Delaminated 270
Deflation Problem 253
Physical Resistance / Sticking 252
Material Integrity Problem 231
Fracture 225
Crack 221
Difficult to Remove 211
Out-Of-Box Failure 197
Material Frayed 193
Difficult to Advance 181
Entrapment of Device 163
Burst Container or Vessel 158
Fluid Leak 151
Mechanical Problem 148
Device Operates Differently Than Expected 147
Device-Device Incompatibility 115
Inflation Problem 112
Difficult to Insert 102
Bent 100
Hole In Material 94
Device Damaged by Another Device 93
Material Fragmentation 83
Material Twisted / Bent 82
Tip 78
Connection Problem 75
Device Contamination with Chemical or Other Material 60
Insufficient Information 58
Material Puncture / Hole 58
Torn Material 56
Device Markings / Labelling Problem 53
Material Split, Cut or Torn 47
Migration or Expulsion of Device 45
Use of Device Problem 45
Deformation Due to Compressive Stress 44
Complete Blockage 42
Device Handling Problem 41
Partial Blockage 38
Split 35
Stretched 35
Gas Leak 33
Product Quality Problem 32
Air Leak 30
Defective Device 29
Mechanical Jam 28
Accessory Incompatible 28
Separation Problem 28
Obstruction of Flow 27
Appropriate Term/Code Not Available 27
Unsealed Device Packaging 26
Occlusion Within Device 25
Device Dislodged or Dislocated 24
Material Perforation 20
Cut In Material 18
Sticking 16
Collapse 16
Human-Device Interface Problem 15
Device Operational Issue 15
Packaging Problem 15
Tear, Rip or Hole in Device Packaging 14
Positioning Problem 14
Compatibility Problem 14
Guidewire 14
Loose or Intermittent Connection 14
Defective Component 14
Contamination During Use 13
Migration 13
Device Inoperable 12
Folded 12
Delivered as Unsterile Product 12
Loss of or Failure to Bond 12
Hub 11
No Flow 11
Improper or Incorrect Procedure or Method 11
Patient-Device Incompatibility 11
Unable to Obtain Readings 10
Material Distortion 10
Component Missing 9
Overheating of Device 9
Device Expiration Issue 9
Device Fell 8
Unintended Movement 8
Material Too Rigid or Stiff 7
Balloon rupture 7
Total Device Problems 16897

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Apr-10-2019
2 Arrow International Inc II Jan-11-2019
3 Arrow International Inc II Jun-29-2018
4 Arrow International Inc II May-30-2018
5 Arrow International Inc II Apr-10-2018
6 Arrow International Inc II Feb-20-2018
7 Arrow International Inc II Jun-12-2017
8 Bard Access Systems II Mar-13-2015
9 Bard Peripheral Vascular Inc II May-11-2018
10 Bard Peripheral Vascular Inc II Apr-10-2015
11 Boston Scientific Corporation II Nov-26-2019
12 Boston Scientific Corporation II Aug-08-2018
13 Boston Scientific Corporation II Jan-05-2016
14 Boston Scientific Corporation II Jun-25-2015
15 Concentric Medical Inc II Oct-09-2015
16 Cook Inc. II Apr-25-2018
17 Cook Inc. II Mar-09-2018
18 Cook Inc. II Aug-22-2016
19 Cook Inc. I Feb-24-2016
20 Cordis Corporation III Apr-18-2019
21 Medtronic Inc I Mar-29-2018
22 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Oct-01-2019
23 Medtronic Vascular II Jun-26-2015
24 Medtronic Vascular, Inc. II Nov-06-2015
25 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
26 ReFlow Medical I Mar-29-2017
27 SPS Sterilization, Inc II Sep-13-2018
28 Stryker Neurovascular II Oct-08-2019
29 Stryker Neurovascular II Jun-02-2019
30 Stryker Neurovascular II Sep-28-2018
31 Stryker Neurovascular II Jul-28-2018
32 Stryker Neurovascular II Nov-02-2016
33 Vascular Solutions, Inc. I May-22-2017
34 Vascular Solutions, Inc. I Oct-20-2016

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