TPLC - Total Product Life Cycle

• Device: stylet, catheter
• 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	116

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	355	2185
Break	73	927
Mechanical Problem	27	759
Material Separation	12	12
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
Crack	1	1
Material Integrity Problem	1	1
Use of Device Problem	1	1
Delivered as Unsterile Product	1	1
Detachment of Device or Device Component	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	193	1779
Cardiac Perforation	176	1030
Pericardial Effusion	108	352
Iatrogenic Source	93	337
No Clinical Signs, Symptoms or Conditions	39	1137
Perforation of Vessels	27	27
Atrial Perforation	22	22
Great Vessel Perforation	21	21
Death	12	12
No Known Impact Or Consequence To Patient	12	12
Cardiac Tamponade	10	10
Low Blood Pressure/ Hypotension	8	8
Pleural Effusion	3	3
Foreign Body In Patient	2	2
Laceration(s)	2	2
No Consequences Or Impact To Patient	2	2
Hemorrhage/Bleeding	2	2
Pulmonary Embolism	2	2
Tricuspid Valve Insufficiency/ Regurgitation	1	1
Perforation	1	1
Atrial Fibrillation	1	1
Obstruction/Occlusion	1	1
Pain	1	1
Bradycardia	1	1
Thrombus	1	1
Internal Organ Perforation	1	1