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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
IMDS OPERATIONS B.V.
  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 4
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
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 2260
Break 1462
Adverse Event Without Identified Device or Use Problem 1001
Material Deformation 928
Balloon 859
Kinked 777
Detachment of Device or device Component 693
Leak / Splash 674
Catheter 582
Device Damaged Prior to Use 544
Failure to Advance 541
Retraction Problem 444
Material Separation 418
Physical Resistance 391
Detachment Of Device Component 357
Physical Resistance / Sticking 332
Shaft 331
Unraveled Material 302
Deflation Problem 284
Peeled / Delaminated 283
Fracture 257
Material Integrity Problem 255
Crack 251
Difficult to Remove 242
Material Frayed 207
Difficult to Advance 204
Out-Of-Box Failure 197
Entrapment of Device 182
Burst Container or Vessel 180
Fluid Leak 161
Mechanical Problem 160
Device Operates Differently Than Expected 147
Inflation Problem 133
Difficult to Insert 122
Device-Device Incompatibility 118
Device Damaged by Another Device 107
Bent 100
Material Twisted / Bent 98
Hole In Material 94
Material Fragmentation 90
Connection Problem 80
Tip 80
Material Puncture / Hole 75
Complete Blockage 69
Material Split, Cut or Torn 69
Device Contamination with Chemical or Other Material 62
Insufficient Information 61
Device Markings / Labelling Problem 61
Torn Material 56
Deformation Due to Compressive Stress 51
Migration or Expulsion of Device 48
Use of Device Problem 48
Device Handling Problem 42
Gas Leak 38
Partial Blockage 38
Stretched 37
Split 35
Product Quality Problem 32
Accessory Incompatible 31
Separation Problem 31
Air Leak 30
Unsealed Device Packaging 30
Appropriate Term/Code Not Available 30
Defective Device 30
Obstruction of Flow 29
Mechanical Jam 28
Occlusion Within Device 25
Device Dislodged or Dislocated 25
Device Sensing Problem 22
Material Perforation 20
Cut In Material 18
Tear, Rip or Hole in Device Packaging 18
Packaging Problem 17
Biocompatibility 17
Collapse 17
Unable to Obtain Readings 16
Loose or Intermittent Connection 16
Improper or Incorrect Procedure or Method 16
Sticking 16
Positioning Problem 15
Device Operational Issue 15
Contamination During Use 15
Defective Component 15
Human-Device Interface Problem 15
Activation, Positioning or Separation Problem 14
Delivered as Unsterile Product 14
Compatibility Problem 14
Guidewire 14
Hub 13
Migration 13
Folded 12
Loss of or Failure to Bond 12
No Flow 11
Patient-Device Incompatibility 11
Material Distortion 10
Device Inoperable 10
Component Missing 10
Fitting Problem 10
Unintended Movement 10
Device Expiration Issue 9
Total Device Problems 18494

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 Arrow International Inc II Apr-10-2019
3 Arrow International Inc II Jan-11-2019
4 Arrow International Inc II Jun-29-2018
5 Arrow International Inc II May-30-2018
6 Arrow International Inc II Apr-10-2018
7 Arrow International Inc II Feb-20-2018
8 Arrow International Inc II Jun-12-2017
9 Bard Access Systems II Mar-13-2015
10 Bard Peripheral Vascular Inc II May-11-2018
11 Bard Peripheral Vascular Inc II Apr-10-2015
12 Boston Scientific Corporation II Nov-26-2019
13 Boston Scientific Corporation II Aug-08-2018
14 Boston Scientific Corporation II Jan-05-2016
15 Boston Scientific Corporation II Jun-25-2015
16 Concentric Medical Inc II Oct-09-2015
17 Cook Inc. II Jun-02-2020
18 Cook Inc. II Apr-25-2018
19 Cook Inc. II Mar-09-2018
20 Cook Inc. II Aug-22-2016
21 Cook Inc. I Feb-24-2016
22 Cordis Corporation III Apr-18-2019
23 Medtronic Inc I Mar-29-2018
24 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Oct-01-2019
25 Medtronic Vascular II Jun-26-2015
26 Medtronic Vascular, Inc. II Nov-06-2015
27 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
28 ReFlow Medical I Mar-29-2017
29 SPS Sterilization, Inc II Sep-13-2018
30 Stryker Neurovascular II Oct-08-2019
31 Stryker Neurovascular II Jun-02-2019
32 Stryker Neurovascular II Sep-28-2018
33 Stryker Neurovascular II Jul-28-2018
34 Stryker Neurovascular II Nov-02-2016
35 Vascular Solutions, Inc. I May-22-2017
36 Vascular Solutions, Inc. I Oct-20-2016

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