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TPLC
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Device
catheter, ultrasound, intravascular
Definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Product Code
OBJ
Regulation Number
870.1200
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACIST MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
BIOSENSE WEBSTER, INC.
SUBSTANTIALLY EQUIVALENT
3
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
3
IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY
SUBSTANTIALLY EQUIVALENT
1
NORTHEAST SCIENTIFIC, INC.
SUBSTANTIALLY EQUIVALENT
1
NUVERA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS IMAGE GUIDED THERAPY CORPORATION
SUBSTANTIALLY EQUIVALENT
2
PROVISIO MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS MEDICAL SOLUTIONS USA, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
237
237
2020
288
1142
2021
353
1573
2022
473
473
2023
697
697
2024
874
874
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
766
1132
Poor Quality Image
542
542
Detachment of Device or Device Component
514
514
Entrapment of Device
459
825
Material Twisted/Bent
236
236
Material Integrity Problem
224
224
Fracture
211
211
Material Deformation
205
327
Failure to Advance
142
142
Material Separation
105
837
Patient Device Interaction Problem
89
89
Physical Resistance/Sticking
79
79
Contamination /Decontamination Problem
77
77
No Display/Image
52
174
Unable to Obtain Readings
48
48
Break
30
30
Leak/Splash
25
25
Device Displays Incorrect Message
25
25
Material Perforation
25
25
Display or Visual Feedback Problem
24
24
Incorrect, Inadequate or Imprecise Result or Readings
23
23
Difficult to Remove
21
265
Difficult to Flush
20
20
Retraction Problem
19
19
Contamination
18
18
Connection Problem
18
18
Difficult to Advance
17
17
Defective Device
16
16
Communication or Transmission Problem
15
15
Output Problem
14
14
Device Contamination with Chemical or Other Material
12
12
Device Sensing Problem
11
11
Activation, Positioning or Separation Problem
11
11
Difficult to Insert
11
11
Material Puncture/Hole
10
10
Tear, Rip or Hole in Device Packaging
10
10
Device-Device Incompatibility
10
10
Insufficient Information
9
9
Therapeutic or Diagnostic Output Failure
9
9
Delivered as Unsterile Product
9
9
Sharp Edges
8
8
Unsealed Device Packaging
7
7
Positioning Problem
7
7
Packaging Problem
7
7
Mechanical Problem
7
7
Noise, Audible
7
7
Protective Measures Problem
6
6
Component Missing
6
6
Material Protrusion/Extrusion
6
6
Image Display Error/Artifact
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2078
2810
No Consequences Or Impact To Patient
302
302
No Known Impact Or Consequence To Patient
95
583
Cardiac Tamponade
92
92
Insufficient Information
68
68
Foreign Body In Patient
58
302
Cardiac Perforation
40
162
Air Embolism
33
33
Non specific EKG/ECG Changes
31
31
No Patient Involvement
26
26
Vascular Dissection
22
144
Cardiac Arrest
22
22
No Code Available
20
20
Pericardial Effusion
18
18
Thrombosis/Thrombus
15
15
Obstruction/Occlusion
15
15
Death
14
14
Chest Pain
13
13
Perforation of Vessels
13
257
Ventricular Fibrillation
10
10
Bradycardia
9
9
Arrhythmia
9
9
Perforation
8
8
Low Blood Pressure/ Hypotension
8
8
Tachycardia
7
7
Myocardial Infarction
7
7
Complaint, Ill-Defined
7
7
Device Embedded In Tissue or Plaque
5
5
Unspecified Tissue Injury
4
4
Hematoma
4
4
Heart Block
4
4
Hemorrhage/Bleeding
4
4
Great Vessel Perforation
3
3
Embolism/Embolus
3
3
Pulmonary Edema
3
3
Atrial Perforation
3
3
Pain
3
3
Stenosis
2
2
Internal Organ Perforation
2
2
Cardiogenic Shock
2
2
ST Segment Elevation
2
2
Restenosis
2
2
Pericarditis
2
2
Rupture
2
2
Blood Loss
2
2
Ischemic Heart Disease
2
2
Ischemia
2
2
Diminished Pulse Pressure
2
2
Failure of Implant
2
2
Stroke/CVA
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Acist Medical Systems
I
Mar-04-2021
2
Boston Scientific Corporation
II
Mar-28-2024
3
Boston Scientific Corporation
II
Oct-22-2020
4
Siemens Medical Solutions USA, Inc.
II
Oct-08-2020
5
Volcano Corp
III
Jun-29-2022
6
Volcano Corporation
II
Jan-11-2019
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