TPLC - Total Product Life Cycle

• Device: catheter, percutaneous, neurovasculature
• Regulation Description: Percutaneous catheter.
• Definition: To provide vascular access to the neurovasculature for interventional or diagnostic procedures
• Product Code: QJP
• Regulation Number: 870.1250
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCUMEDICAL BEIJING LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALEMBIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
ANOXIA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
AQURE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASAHI INTECC CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
ASAHI INTECC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
BALT USA, LLC
	SUBSTANTIALLY EQUIVALENT	4
BEND IT TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
CERENOVUS INC.
	SUBSTANTIALLY EQUIVALENT	1
CERENOVUS, INC.
	SUBSTANTIALLY EQUIVALENT	3
CERUS ENDOVASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS NEUROVASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJI SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU EASYCESS MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
IMPERATIVE CARE INC.
	SUBSTANTIALLY EQUIVALENT	4
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
KAI MEDTECH, LLC
	SUBSTANTIALLY EQUIVALENT	1
MADURO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
MARBLEHEAD MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MARBLEHEAD MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION, INC.
	SUBSTANTIALLY EQUIVALENT	2
MIVI NEUROSCIENCE, INC
	SUBSTANTIALLY EQUIVALENT	1
MIVI NEUROSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEURAVI LIMITED
	SUBSTANTIALLY EQUIVALENT	2
PENUMBRA, INC
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	4
PERFUZE LTD.
	SUBSTANTIALLY EQUIVALENT	4
PIRAEUS MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
Q'APEL MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
Q'APEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
REV NEURO LLC
	SUBSTANTIALLY EQUIVALENT	1
RIST NEUROVASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	2
ROUTE 92 MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ROUTE 92 MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
ROUTE 92 MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
SCIENTIA VASCULAR INC
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPARTAN MICRO
	SUBSTANTIALLY EQUIVALENT	1
STRYKER NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	7
UNITY MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
UNITY MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WALLABY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	16	16
2021	26	26
2022	29	29
2023	75	75
2024	124	124
2025	500	500

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	310	310
Adverse Event Without Identified Device or Use Problem	156	156
Crack	70	70
Material Twisted/Bent	51	51
Break	44	44
Material Deformation	37	37
Material Separation	34	34
Difficult to Advance	33	33
Fluid/Blood Leak	21	21
Burst Container or Vessel	19	19
Deformation Due to Compressive Stress	14	14
Fracture	13	13
Deflation Problem	13	13
No Apparent Adverse Event	12	12
Unintended Movement	12	12
Stretched	12	12
Difficult to Remove	10	10
Insufficient Information	8	8
Device Damaged by Another Device	7	7
Inflation Problem	6	6
Device-Device Incompatibility	5	5
Failure to Deflate	5	5
Material Too Soft/Flexible	5	5
Wrong Label	4	4
Packaging Problem	4	4
Flaked	3	3
Retraction Problem	3	3
Product Quality Problem	3	3
Unsealed Device Packaging	3	3
Peeled/Delaminated	3	3
Leak/Splash	3	3
Contamination /Decontamination Problem	2	2
Material Integrity Problem	2	2
Collapse	2	2
Entrapment of Device	2	2
Failure to Advance	2	2
Separation Problem	2	2
Material Split, Cut or Torn	2	2
Material Fragmentation	1	1
Unintended Ejection	1	1
Air/Gas in Device	1	1
Difficult or Delayed Positioning	1	1
Expiration Date Error	1	1
Delivered as Unsterile Product	1	1
Material Rupture	1	1
Defective Component	1	1
Material Puncture/Hole	1	1
Detachment of Device or Device Component	1	1
Malposition of Device	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	578	578
Intracranial Hemorrhage	46	46
Ischemia Stroke	33	33
Vasoconstriction	24	24
Vascular Dissection	23	23
Headache	19	19
Obstruction/Occlusion	18	18
Thromboembolism	16	16
Hematoma	14	14
Stroke/CVA	12	12
Hemorrhage/Bleeding	12	12
Embolism/Embolus	12	12
Hemorrhagic Stroke	12	12
Swelling/ Edema	11	11
Ischemia	11	11
Pain	10	10
Bacterial Infection	9	9
Aneurysm	8	8
Perforation of Vessels	8	8
Visual Disturbances	8	8
Fistula	7	7
No Consequences Or Impact To Patient	7	7
Thrombosis/Thrombus	7	7
Foreign Body In Patient	7	7
Dysphasia	5	5
Stenosis	5	5
Paresis	5	5
Rupture	5	5
Confusion/ Disorientation	5	5
Transient Ischemic Attack	5	5
Insufficient Information	4	4
Paralysis	4	4
Muscle Weakness	4	4
Nausea	4	4
Skin Discoloration	3	3
Fever	3	3
Cardiac Arrest	3	3
Bruise/Contusion	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Respiratory Insufficiency	3	3
Dizziness	3	3
Blurred Vision	3	3
Pseudoaneurysm	3	3
Ruptured Aneurysm	3	3
Cognitive Changes	2	2
Cerebral Edema	2	2
Chest Pain	2	2
High Blood Pressure/ Hypertension	2	2
Nervous System Injury	2	2
Visual Impairment	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Medos International Sarl	I	Mar-13-2024
2	ROUTE 92 MEDICAL INC	I	Apr-24-2024
3	Scientia Vascular, Inc.	II	Feb-26-2025
4	Stryker Neurovascular	II	Oct-07-2024
5	Stryker Neurovascular	II	May-28-2024
6	Stryker, Inc.	II	Feb-14-2024