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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, septostomy
Regulation Description Septostomy catheter.
Product CodeDXF
Regulation Number 870.5175
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRAVERSE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ATRAVERSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
CIRCA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CROSS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K221528  Fogarty Dilation Atrioseptostomy Catheter, Miller ...
ELECTROWIRE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 24 24
2020 55 55
2021 39 39
2022 70 70
2023 286 292
2024 368 368
2025 692 692
2026 535 535

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1018 1024
Difficult to Advance 248 248
Failure to Advance 225 225
Material Integrity Problem 185 185
Display or Visual Feedback Problem 107 108
Positioning Problem 97 98
Material Deformation 79 79
Physical Resistance/Sticking 72 72
Use of Device Problem 69 69
Device Sensing Problem 55 55
Off-Label Use 42 42
Detachment of Device or Device Component 41 41
Nonstandard Device 32 32
Device-Device Incompatibility 31 31
Deformation Due to Compressive Stress 25 25
Difficult to Remove 25 25
Defective Device 21 21
Device Dislodged or Dislocated 20 20
Difficult to Insert 20 20
Material Frayed 17 17
Thermal Decomposition of Device 17 17
Burst Container or Vessel 15 15
Contamination 15 15
Insufficient Device Problem Information 15 15
Packaging Problem 12 12
Failure to Deliver Energy 10 10
Tear, Rip or Hole in Device Packaging 9 9
Unsealed Device Packaging 9 9
Device Displays Incorrect Message 8 8
Difficult to Open or Remove Packaging Material 7 7
Mechanics Altered 6 6
Delivered as Unsterile Product 4 4
Obstruction of Flow 4 4
Break 4 4
Device Contaminated During Manufacture or Shipping 4 4
Difficult or Delayed Positioning 3 3
Material Rupture 3 3
High impedance 3 3
Fracture 3 3
Human-Device Interface Problem 3 3
Leak/Splash 3 3
Improper Flow or Infusion 2 2
Positioning Failure 2 2
Material Fragmentation 2 2
Unintended Movement 2 2
Patient-Device Incompatibility 2 2
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Intermittent Communication Failure 2 2
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 988 990
No Clinical Signs, Symptoms or Conditions 599 599
Low Blood Pressure/ Hypotension 492 493
Cardiac Tamponade 387 388
Cardiac Perforation 328 328
Thrombosis/Thrombus 123 125
Perforation of Vessels 94 94
Hematoma 74 74
Cardiac Arrest 68 68
Hemorrhage/Blood Loss/Bleeding 53 53
Perforation 52 55
Tachycardia 43 43
Arrhythmia 34 34
Bradycardia 28 28
Non specific EKG/ECG Changes 27 27
Chest Pain 26 26
Stroke/CVA 25 25
Air Embolism 19 19
Asystole 18 18
Pleural Effusion 17 17
Vascular Dissection 17 17
High Blood Pressure/ Hypertension 16 16
Heart Block 16 16
No Consequences Or Impact To Patient 15 15
Dyspnea 13 13
Unspecified Tissue Injury 12 12
Atrial Fibrillation 12 12
Swelling/ Edema 10 10
Foreign Body In Patient 10 10
Ventricular Fibrillation 10 10
Ischemia Stroke 10 10
Hypoxia 9 9
Hemothorax 8 8
Fistula 7 7
Death 7 7
Pain 6 6
Embolism/Embolus 6 6
Insufficient Information 5 5
Retroperitoneal Hemorrhage 5 5
Respiratory Arrest 5 5
Pericarditis 5 5
Heart Failure/Congestive Heart Failure 5 5
Atrial Flutter 4 4
Loss of consciousness 4 4
Respiratory Failure 4 4
No Known Impact Or Consequence To Patient 4 4
Hypersensitivity/Allergic reaction 4 4
Diminished Pulse Pressure 4 4
Speech Disorder 4 4
Pseudoaneurysm 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-10-2025
2 Edwards Lifesciences, LLC I Apr-25-2019
3 Medtronic Vascular I Oct-16-2020
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