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 CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
XLUMENA, INC
	GRANTED	1
XLUMENA, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	339	339
Positioning Problem	315	315
Activation, Positioning or Separation Problem	206	206
Adverse Event Without Identified Device or Use Problem	189	189
Activation Failure	152	152
Positioning Failure	119	119
Premature Activation	117	117
Migration	94	94
Break	90	90
Difficult to Remove	75	75
Detachment of Device or Device Component	62	62
Entrapment of Device	56	56
Difficult or Delayed Positioning	49	49
Electrical /Electronic Property Problem	45	45
Migration or Expulsion of Device	40	40
Material Integrity Problem	36	36
Difficult to Advance	33	33
Appropriate Term/Code Not Available	30	30
Obstruction of Flow	26	26
Material Deformation	23	23
Device-Device Incompatibility	22	22
Device Stenosis	17	17
Mechanical Problem	17	17
Failure to Conduct	16	16
Defective Device	16	16
Human-Device Interface Problem	14	14
Partial Blockage	14	14
Poor Visibility	8	8
Connection Problem	7	7
Unsealed Device Packaging	5	5
Mechanical Jam	5	5
Detachment Of Device Component	4	4
Failure to Advance	3	3
Material Perforation	2	2
Fracture	2	2
Occlusion Within Device	2	2
Retraction Problem	2	2
Material Separation	2	2
Activation Problem	2	2
Packaging Problem	1	1
Off-Label Use	1	1
Energy Output Problem	1	1
Grounding Malfunction	1	1
Component Missing	1	1
Malposition of Device	1	1
Inadequate User Interface	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Operates Differently Than Expected	1	1
Device Dislodged or Dislocated	1	1
Extrusion	1	1
Device Contamination with Chemical or Other Material	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	370	370
Hemorrhage/Bleeding	126	126
No Code Available	59	59
No Known Impact Or Consequence To Patient	44	44
Perforation	36	36
Insufficient Information	30	30
Unspecified Infection	25	25
Abdominal Pain	21	21
Death	19	19
Erosion	18	18
Fever	16	16
Obstruction/Occlusion	16	16
Pain	16	16
Fistula	13	13
Peritonitis	11	11
Vomiting	9	9
Injury	7	7
Bowel Perforation	7	7
Sepsis	6	6
Septic Shock	5	5
Internal Organ Perforation	4	4
Laceration(s)	4	4
Hematoma	4	4
Multiple Organ Failure	4	4
Pseudoaneurysm	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hematemesis	4	4
Jaundice	4	4
Stenosis	3	3
Nausea	3	3
Pneumonia	3	3
Shock	3	3
Abscess	3	3
Aneurysm	2	2
Bacterial Infection	2	2
Diarrhea	2	2
Purulent Discharge	2	2
Dyspnea	2	2
Inflammation	2	2
Ulcer	2	2
Discomfort	2	2
Thrombus	2	2
Abdominal Distention	2	2
Decreased Appetite	2	2
Swelling/ Edema	2	2
Embolism/Embolus	2	2
Constipation	1	1
Foreign Body In Patient	1	1
Device Embedded In Tissue or Plaque	1	1
Pancreatitis	1	1
Skin Inflammation/ Irritation	1	1
Unspecified Tissue Injury	1	1
Electric Shock	1	1
Ascites	1	1
Sore Throat	1	1
Discharge	1	1
Tissue Damage	1	1
Urinary Tract Infection	1	1
Complaint, Ill-Defined	1	1
Necrosis	1	1
Hemoptysis	1	1
Low Blood Pressure/ Hypotension	1	1
Hypovolemic Shock	1	1
Tachycardia	1	1
Rash	1	1
Syncope	1	1
Edema	1	1
Flatus	1	1
Pyrosis/Heartburn	1	1
Bradycardia	1	1
Cardiac Arrest	1	1
Adhesion(s)	1	1
Anemia	1	1

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