TPLC - Total Product Life Cycle

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Device	pancreatic stent, covered, metallic, removable
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	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	333	333
Positioning Problem	302	302
Activation, Positioning or Separation Problem	203	203
Activation Failure	136	136
Positioning Failure	109	109
Migration	87	87
Break	80	80
Premature Activation	77	77
Adverse Event Without Identified Device or Use Problem	72	72
Entrapment of Device	55	55
Difficult to Remove	49	49
Difficult or Delayed Positioning	47	47
Detachment of Device or Device Component	46	46
Electrical /Electronic Property Problem	45	45
Material Integrity Problem	34	34
Difficult to Advance	33	33
Obstruction of Flow	23	23
Device-Device Incompatibility	21	21
Material Deformation	21	21
Appropriate Term/Code Not Available	21	21
Device Stenosis	17	17
Defective Device	16	16
Failure to Conduct	16	16
Mechanical Problem	16	16
Human-Device Interface Problem	9	9
Poor Visibility	8	8
Connection Problem	7	7
Mechanical Jam	4	4
Unsealed Device Packaging	4	4
Material Perforation	2	2
Material Separation	2	2
Failure to Advance	2	2
Activation Problem	2	2
Packaging Problem	1	1
Component Missing	1	1
Retraction Problem	1	1
Off-Label Use	1	1
Migration or Expulsion of Device	1	1
Energy Output Problem	1	1
Grounding Malfunction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	589	589
No Consequences Or Impact To Patient	210	210
Hemorrhage/Bleeding	66	66
No Code Available	44	44
Insufficient Information	30	30
Perforation	23	23
Abdominal Pain	17	17
No Known Impact Or Consequence To Patient	16	16
Obstruction/Occlusion	13	13
Unspecified Infection	12	12
Fever	10	10
Fistula	9	9
Pain	7	7
Bowel Perforation	7	7
Peritonitis	6	6
Sepsis	5	5
Erosion	5	5
Death	4	4
Septic Shock	4	4
Hematemesis	4	4
Vomiting	4	4
Injury	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Multiple Organ Failure	3	3
Nausea	3	3
Internal Organ Perforation	3	3
Hematoma	3	3
Diarrhea	2	2
Purulent Discharge	2	2
Dyspnea	2	2
Laceration(s)	2	2
Ulcer	2	2
Discomfort	2	2
Pseudoaneurysm	2	2
Jaundice	2	2
Embolism/Embolus	2	2
Decreased Appetite	2	2
Swelling/ Edema	2	2
Sore Throat	1	1
Electric Shock	1	1
Ascites	1	1
Abdominal Distention	1	1
Constipation	1	1
Pancreatitis	1	1
Skin Inflammation/ Irritation	1	1
Unspecified Tissue Injury	1	1
Tachycardia	1	1
Rash	1	1
Inflammation	1	1
Low Blood Pressure/ Hypotension	1	1
Edema	1	1
Abscess	1	1
Adhesion(s)	1	1
Anemia	1	1
Aneurysm	1	1
Bacterial Infection	1	1
Hemoptysis	1	1
Bradycardia	1	1
Flatus	1	1
Pyrosis/Heartburn	1	1

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