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U.S. Department of Health and Human Services

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 CodePCU
Regulation Number 876.5015
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 135 135
2020 144 144
2021 162 162
2022 208 208
2023 260 260
2024 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 340 340
Positioning Problem 309 309
Activation, Positioning or Separation Problem 213 213
Activation Failure 141 141
Positioning Failure 112 112
Migration 88 88
Break 82 82
Premature Activation 81 81
Adverse Event Without Identified Device or Use Problem 76 76
Entrapment of Device 57 57
Difficult or Delayed Positioning 49 49
Difficult to Remove 49 49
Detachment of Device or Device Component 47 47
Electrical /Electronic Property Problem 45 45
Material Integrity Problem 35 35
Difficult to Advance 34 34
Material Deformation 24 24
Obstruction of Flow 23 23
Device-Device Incompatibility 22 22
Appropriate Term/Code Not Available 21 21
Defective Device 18 18
Device Stenosis 18 18
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 614 614
No Consequences Or Impact To Patient 210 210
Hemorrhage/Bleeding 69 69
No Code Available 44 44
Insufficient Information 32 32
Perforation 24 24
Abdominal Pain 17 17
No Known Impact Or Consequence To Patient 16 16
Obstruction/Occlusion 13 13
Unspecified Infection 12 12
Fever 11 11
Fistula 9 9
Pain 7 7
Peritonitis 7 7
Bowel Perforation 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Sepsis 6 6
Erosion 5 5
Vomiting 5 5
Injury 4 4
Hematemesis 4 4
Death 4 4
Septic Shock 4 4
Nausea 4 4
Internal Organ Perforation 3 3
Hematoma 3 3
Multiple Organ Failure 3 3
Pseudoaneurysm 2 2
Embolism/Embolus 2 2
Jaundice 2 2
Unspecified Tissue Injury 2 2
Decreased Appetite 2 2
Swelling/ Edema 2 2
Diarrhea 2 2
Purulent Discharge 2 2
Dyspnea 2 2
Laceration(s) 2 2
Ulcer 2 2
Discomfort 2 2
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
Sore Throat 1 1
Electric Shock 1 1
Ascites 1 1
Abdominal Distention 1 1
Pancreatitis 1 1
Skin Inflammation/ Irritation 1 1
Constipation 1 1

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