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	474	474
Positioning Problem	318	318
Activation, Positioning or Separation Problem	305	305
Activation Failure	262	263
Adverse Event Without Identified Device or Use Problem	226	226
Positioning Failure	216	216
Migration	106	106
Break	88	88
Premature Activation	73	73
Entrapment of Device	71	71
Detachment of Device or Device Component	67	67
Electrical /Electronic Property Problem	65	65
Difficult or Delayed Positioning	60	60
Device Stenosis	53	53
Difficult to Remove	52	52
Difficult to Advance	42	42
Material Integrity Problem	40	40
Material Deformation	37	37
Human-Device Interface Problem	22	22
Failure to Conduct	22	22
Appropriate Term/Code Not Available	17	17
Device-Device Incompatibility	15	15
Defective Device	14	14
Poor Visibility	14	14
Mechanical Problem	13	13
Retraction Problem	11	11
Difficult or Delayed Activation	11	11
Obstruction of Flow	10	10
Material Separation	9	9
Connection Problem	8	8
Mechanical Jam	4	4
Component Missing	3	3
Energy Output Problem	3	3
Material Perforation	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Unsealed Device Packaging	2	2
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Fire	1	1
Activation Problem	1	1
Off-Label Use	1	1
Grounding Malfunction	1	1
Nonstandard Device	1	1
Migration or Expulsion of Device	1	1
Deformation Due to Compressive Stress	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1120	1120
Hemorrhage/Bleeding	109	109
Insufficient Information	60	61
Perforation	57	57
Abdominal Pain	35	35
Fever	24	24
Fistula	23	23
Vomiting	20	20
Unspecified Infection	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Obstruction/Occlusion	17	17
Inflammation	16	16
Peritonitis	15	15
Sepsis	13	13
Pain	13	13
Erosion	12	12
Ulcer	12	12
Pancreatitis	10	10
Bowel Perforation	9	9
Multiple Organ Failure	7	7
Hypovolemic Shock	6	6
Ascites	6	6
Nausea	6	6
Abscess	6	6
Discomfort	6	6
Septic Shock	6	6
Anemia	6	6
No Consequences Or Impact To Patient	5	5
Swelling/ Edema	5	5
Unspecified Tissue Injury	5	5
Pneumonia	5	5
Hematemesis	5	5
Internal Organ Perforation	4	4
Jaundice	4	4
Hematoma	4	4
Bacterial Infection	4	4
Decreased Appetite	3	3
Diarrhea	3	3
Low Blood Pressure/ Hypotension	3	3
Embolism/Embolus	3	3
Pseudoaneurysm	3	3
Cardiac Arrest	2	2
Pyrosis/Heartburn	2	2
No Known Impact Or Consequence To Patient	2	2
Purulent Discharge	2	2
Foreign Body In Patient	2	2
Pleural Effusion	2	2
Syncope/Fainting	2	2
Dyspnea	2	2
Laceration(s)	2	2

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