TPLC - Total Product Life Cycle

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Device	system, balloon, intra-aortic and control
Product Code	DSP
Regulation Number	870.3535
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARROW INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	2
ARROW INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
ARROW INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ARROW INTERNATIONAL, TELEFLEX
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	2553	2553
Gas/Air Leak	2093	2093
Leak/Splash	1731	1731
Inability to Auto-Fill	1503	1503
Optical Problem	1232	1232
Break	1219	1219
Battery Problem	1090	1090
Failure to Sense	1041	1041
Incorrect, Inadequate or Imprecise Result or Readings	926	926
Display or Visual Feedback Problem	893	893
Unexpected Shutdown	855	855
Failure to Power Up	742	742
Pressure Problem	712	712
Inflation Problem	709	709
Device Displays Incorrect Message	696	696
Failure to Charge	632	632
Difficult to Insert	589	589
No Display/Image	581	581
Erratic or Intermittent Display	579	579
Premature Discharge of Battery	539	539
Device Contamination with Body Fluid	523	523
Fluid/Blood Leak	455	455
Overheating of Device	450	450
Noise, Audible	397	397
Power Problem	378	378
Device Contamination with Chemical or Other Material	377	377
Device Alarm System	337	337
Pumping Stopped	333	333
Connection Problem	315	315
Calibration Problem	310	310
Material Deformation	309	309
Communication or Transmission Problem	258	258
Inappropriate Waveform	242	242
Charging Problem	234	234
Electrical /Electronic Property Problem	233	233
Material Rupture	227	227
Difficult to Advance	203	203
Output Problem	199	199
Retraction Problem	186	186
Material Integrity Problem	181	181
No Apparent Adverse Event	162	162
Failure to Zero	158	158
Moisture or Humidity Problem	152	152
Mechanical Problem	151	151
Backflow	147	147
Adverse Event Without Identified Device or Use Problem	135	135
No Device Output	134	134
Failure to Calibrate	131	131
Decrease in Suction	125	125
Filling Problem	124	124

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19322	19322
Insufficient Information	3462	3462
No Consequences Or Impact To Patient	3208	3208
No Patient Involvement	3026	3026
No Known Impact Or Consequence To Patient	1366	1366
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	288	288
Death	169	169
Low Blood Pressure/ Hypotension	73	73
Injury	65	65
Cardiac Arrest	58	58
Needle Stick/Puncture	54	54
No Information	43	43
Hemorrhage/Bleeding	30	30
Failure of Implant	22	22
Tachycardia	21	21
Myocardial Infarction	19	19
Cardiogenic Shock	19	19
Chest Pain	19	19
Pain	14	14
Vascular Dissection	14	14
Abdominal Pain	12	12
Diminished Pulse Pressure	11	11
Ischemia	11	11
Thrombus	11	11
Arrhythmia	11	11
Calcium Deposits/Calcification	11	12
Hematoma	10	10
Stroke/CVA	10	10
Ventricular Fibrillation	10	10
Bradycardia	9	9
Thrombosis/Thrombus	9	9
Pseudoaneurysm	9	9
No Code Available	8	9
Foreign Body In Patient	8	8
Air Embolism	8	8
High Blood Pressure/ Hypertension	7	7
Perforation	7	7
Low Cardiac Output	7	7
Atrial Fibrillation	7	7
Device Embedded In Tissue or Plaque	6	6
Dyspnea	6	6
Blood Loss	6	6
Cardiac Tamponade	5	5
Shock	5	5
Fever	5	5
Heart Failure/Congestive Heart Failure	5	5
Loss of consciousness	5	5
Nausea	5	5
Unspecified Vascular Problem	5	5
Low Oxygen Saturation	5	5