TPLC - Total Product Life Cycle

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Device	pancreatic stent, covered, metallic, removable
Regulation Description	Pancreatic drainage stent and delivery system.
Definition	To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Product Code	PCU
Regulation Number	876.5015
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TAEWOONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	491	491
Positioning Problem	334	334
Positioning Failure	317	317
Activation, Positioning or Separation Problem	307	307
Adverse Event Without Identified Device or Use Problem	290	290
Activation Failure	269	269
Migration	109	109
Break	101	101
Premature Activation	74	74
Entrapment of Device	74	74
Detachment of Device or Device Component	71	71
Electrical /Electronic Property Problem	69	69
Difficult or Delayed Positioning	62	62
Device Stenosis	54	54
Difficult to Remove	51	51
Difficult to Advance	45	45
Material Integrity Problem	40	40
Material Deformation	37	37
Failure to Conduct	26	26
Human-Device Interface Problem	22	22
Appropriate Device Problem Term/Code Not Available	17	17
Device-Device Incompatibility	16	16
Poor Visibility	15	15
Defective Device	13	13
Difficult or Delayed Activation	12	12
Mechanical Problem	12	12
Retraction Problem	11	11
Obstruction of Flow	10	10
Material Separation	9	9
Connection Problem	9	9
Mechanical Jam	4	4
Component Missing	3	3
Energy Output Problem	3	3
Nonstandard Device	3	3
Material Perforation	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Unsealed Device Packaging	2	2
Deformation Due to Compressive Stress	2	2
Packaging Problem	1	1
Failure to Fire	1	1
Off-Label Use	1	1
Overheating of Device	1	1
Device Slipped	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1255	1255
Hemorrhage/Blood Loss/Bleeding	116	116
Insufficient Information	60	61
Perforation	59	59
Abdominal Pain	35	35
Fever	25	25
Fistula	23	23
Vomiting	20	20
Unspecified Infection	19	19
Cholangitis	18	18
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	17	17
Biliary Leak	17	17
Obstruction/Occlusion	17	17
Inflammation	16	16
Peritonitis	15	15
Sepsis	14	14
Pain	14	14
Erosion	12	12
Ulcer	12	12
Pancreatitis	10	10
Bowel Perforation	9	9
Hypovolemic Shock	7	7
Multiple Organ Dysfunction Syndrome	7	7
Discomfort	7	7
Ascites	6	6
Anemia	6	6
Nausea	6	6
Unspecified Tissue Injury	6	6
Abscess	6	6
Septic Shock	6	6
No Consequences Or Impact To Patient	5	5
Swelling/ Edema	5	5
Pneumonia	5	5
Hematemesis	5	5
Internal Organ Perforation	4	4
Hematoma	4	4
Low Blood Pressure/ Hypotension	4	4
Bacterial Infection	4	4
Foreign Body In Patient	4	4
Jaundice	4	4
Decreased Appetite	3	3
Pseudoaneurysm	3	3
Diarrhea	3	3
Embolism/Embolus	3	3
Pleural Effusion	2	2
Heartburn/Indigestion	2	2
Dyspnea	2	2
Syncope/Fainting	2	2
Laceration(s)	2	2
High White Blood Cell Count	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jan-06-2021