TPLC - Total Product Life Cycle

• Device: stylet, catheter
• Regulation Description: Catheter stylet.
• Product Code: DRB
• Regulation Number: 870.1380
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	92	92
2021	97	3635
2022	94	94
2023	82	82
2024	116	120
2025	145	145

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	437	2269
Break	90	946
Packaging Problem	31	31
Mechanical Problem	27	761
Material Separation	21	21
Material Integrity Problem	3	3
Activation, Positioning or Separation Problem	2	2
Physical Resistance/Sticking	2	2
Device Damaged by Another Device	2	2
Product Quality Problem	2	2
Mechanical Jam	2	124
Device Slipped	1	1
Device Contaminated During Manufacture or Shipping	1	1
Entrapment of Device	1	1
Crack	1	1
Accessory Incompatible	1	1
Contamination	1	1
Use of Device Problem	1	1
Delivered as Unsterile Product	1	1
Detachment of Device or Device Component	1	1
Tear, Rip or Hole in Device Packaging	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	241	1827
Cardiac Perforation	221	1075
Pericardial Effusion	153	398
Iatrogenic Source	93	337
No Clinical Signs, Symptoms or Conditions	80	1178
Perforation of Vessels	34	34
Great Vessel Perforation	27	27
Atrial Perforation	22	22
Cardiac Tamponade	13	13
Death	12	12
No Known Impact Or Consequence To Patient	12	12
Low Blood Pressure/ Hypotension	10	12
Pleural Effusion	3	3
Tricuspid Valve Insufficiency/ Regurgitation	2	2
Pericarditis	2	2
Foreign Body In Patient	2	3
Laceration(s)	2	2
Hemorrhage/Bleeding	2	2
No Consequences Or Impact To Patient	2	2
Pulmonary Embolism	2	2
Perforation	1	1
Obstruction/Occlusion	1	2
Atrial Fibrillation	1	1
Pain	1	1
Bradycardia	1	1
Hemothorax	1	1
Internal Organ Perforation	1	1
Thrombus	1	1