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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
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED CATHETER THERAPIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASAHI
  SUBSTANTIALLY EQUIVALENT 8
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
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 5
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 5
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
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
MIVI, LLC
  SUBSTANTIALLY EQUIVALENT 1
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 3
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ROXWOOD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
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 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
SUREFIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 7

Device Problems
Material Rupture 1878
Break 1360
Balloon 867
Kinked 857
Adverse Event Without Identified Device or Use Problem 853
Material Deformation 724
Leak / Splash 633
Detachment of Device or device Component 609
Catheter 576
Device Damaged Prior to Use 512
Retraction Problem 495
Failure to Advance 469
Material Separation 412
Physical Resistance 396
Detachment Of Device Component 369
Shaft 329
Unraveled Material 306
Deflation Problem 295
Peeled / Delaminated 272
Physical Resistance / Sticking 220
Fracture 220
Crack 217
Material Integrity Problem 216
Out-Of-Box Failure 197
Difficult to Remove 197
Material Frayed 192
Difficult to Advance 175
Burst Container or Vessel 155
Entrapment of Device 152
Device Operates Differently Than Expected 149
Mechanical Problem 143
Fluid Leak 143
Device-Device Incompatibility 118
Inflation Problem 110
Bent 100
Difficult to Insert 100
Hole In Material 97
Device Damaged by Another Device 89
Material Fragmentation 81
Tip 79
Connection Problem 75
Material Twisted / Bent 72
Device Contamination with Chemical or Other Material 60
Torn Material 59
Material Puncture / Hole 56
Insufficient Information 54
Device Markings / Labelling Problem 53
Migration or Expulsion of Device 51
Stretched 47
Partial Blockage 45
Deformation Due to Compressive Stress 44
Occlusion Within Device 44
Device Handling Problem 41
Use of Device Problem 40
Material Split, Cut or Torn 40
Split 39
Complete Blockage 38
Obstruction of Flow 36
Product Quality Problem 33
Gas Leak 33
Balloon rupture 30
Air Leak 30
Separation Problem 28
Mechanical Jam 28
Defective Device 28
Unsealed Device Packaging 26
Appropriate Term/Code Not Available 26
Accessory Incompatible 24
Device Dislodged or Dislocated 23
Cut In Material 19
Improper or Incorrect Procedure or Method 19
Material Perforation 19
Sticking 18
Collapse 17
Human-Device Interface Problem 16
Packaging Problem 16
Tear, Rip or Hole in Device Packaging 15
Device Operational Issue 15
Loose or Intermittent Connection 15
Defective Component 14
Compatibility Problem 14
Guidewire 14
Positioning Problem 13
Migration 13
Folded 13
Device Inoperable 12
Loss of or Failure to Bond 12
No Flow 11
Unable to Obtain Readings 11
Patient-Device Incompatibility 11
Contamination During Use 10
Material Distortion 10
Delivered as Unsterile Product 10
Hub 10
Device Expiration Issue 9
Overheating of Device 9
Positioning Failure 8
Fitting Problem 8
Device Fell 8
Material Too Rigid or Stiff 7
Total Device Problems 16961

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 Arrow International Inc II Oct-16-2014
9 Arrow International Inc II Oct-14-2014
10 Bard Access Systems II Mar-13-2015
11 Bard Peripheral Vascular Inc II May-11-2018
12 Bard Peripheral Vascular Inc II Apr-10-2015
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 Boston Scientific Corporation II Mar-10-2014
17 Concentric Medical Inc II Oct-09-2015
18 Concentric Medical Inc II Dec-12-2014
19 Cook Inc. II Apr-25-2018
20 Cook Inc. II Mar-09-2018
21 Cook Inc. II Aug-22-2016
22 Cook Inc. I Feb-24-2016
23 Cordis Corporation III Apr-18-2019
24 Ev3, Inc. II Apr-23-2014
25 Medtronic Inc I Mar-29-2018
26 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Oct-01-2019
27 Medtronic Vascular II Jun-26-2015
28 Medtronic Vascular II Nov-13-2014
29 Medtronic Vascular, Inc. II Nov-06-2015
30 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
31 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Apr-16-2014
32 ReFlow Medical I Mar-29-2017
33 SPS Sterilization, Inc II Sep-13-2018
34 Stryker Neurovascular II Oct-08-2019
35 Stryker Neurovascular II Jun-02-2019
36 Stryker Neurovascular II Sep-28-2018
37 Stryker Neurovascular II Jul-28-2018
38 Stryker Neurovascular II Nov-02-2016
39 Vascular Solutions, Inc. I May-22-2017
40 Vascular Solutions, Inc. I Oct-20-2016

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