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	402	402
Positioning Problem	358	358
Activation, Positioning or Separation Problem	252	252
Adverse Event Without Identified Device or Use Problem	234	234
Activation Failure	192	192
Positioning Failure	143	143
Premature Activation	125	125
Migration	115	115
Break	99	99
Difficult to Remove	84	84
Detachment of Device or Device Component	67	67
Entrapment of Device	61	61
Difficult or Delayed Positioning	54	54
Electrical /Electronic Property Problem	47	47
Material Integrity Problem	41	41
Migration or Expulsion of Device	40	40
Difficult to Advance	37	37
Device Stenosis	37	37
Appropriate Term/Code Not Available	30	30
Material Deformation	29	29
Human-Device Interface Problem	26	26
Obstruction of Flow	26	26
Device-Device Incompatibility	23	23
Defective Device	21	21
Failure to Conduct	18	18
Mechanical Problem	17	17
Partial Blockage	14	14
Poor Visibility	10	10
Connection Problem	8	8
Material Separation	5	5
Unsealed Device Packaging	5	5
Mechanical Jam	5	5
Detachment Of Device Component	4	4
Failure to Advance	3	3
Component Missing	2	2
Occlusion Within Device	2	2
Retraction Problem	2	2
Fracture	2	2
Material Perforation	2	2
Activation Problem	2	2
Device Contamination with Chemical or Other Material	1	1
Off-Label Use	1	1
Malposition of Device	1	1
Difficult to Open or Close	1	1
Device Dislodged or Dislocated	1	1
Device Operates Differently Than Expected	1	1
Packaging Problem	1	1
Energy Output Problem	1	1
Inadequate User Interface	1	1
Grounding Malfunction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	735	735
No Consequences Or Impact To Patient	370	370
Hemorrhage/Bleeding	155	155
No Code Available	59	59
Perforation	54	54
Insufficient Information	48	48
No Known Impact Or Consequence To Patient	44	44
Abdominal Pain	29	29
Unspecified Infection	29	29
Fever	24	24
Erosion	23	23
Fistula	20	20
Obstruction/Occlusion	20	20
Death	19	19
Vomiting	19	19
Pain	17	17
Peritonitis	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Sepsis	11	11
Inflammation	11	11
Bowel Perforation	8	8
Multiple Organ Failure	8	8
Hypovolemic Shock	7	7
Pneumonia	7	7
Injury	7	7
Septic Shock	7	7
Ascites	5	5
Nausea	5	5
Pseudoaneurysm	5	5
Abscess	5	5
Jaundice	5	5
Internal Organ Perforation	4	4
Hematoma	4	4
Shock	4	4
Hematemesis	4	4
Laceration(s)	4	4
Decreased Appetite	3	3
Ulcer	3	3
Stenosis	3	3
Discomfort	3	3
Diarrhea	3	3
Cardiac Arrest	3	3
Anemia	3	3
Embolism/Embolus	3	3
Pancreatitis	3	3
Pleural Effusion	2	2
Dyspnea	2	2
Purulent Discharge	2	2
Perforation of Vessels	2	2
Unspecified Tissue Injury	2	2

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