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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device esophageal dilator balloon with or without electrode sensors
Definition To dilate the lower esophageal sphincter of patients with Achalasia.
Product CodePID
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 4 4
2021 10 10
2022 9 9
2023 10 10
2024 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Device Difficult to Program or Calibrate 50 50
Adverse Event Without Identified Device or Use Problem 17 17
Insufficient Information 13 13
Burst Container or Vessel 13 13
Inadequacy of Device Shape and/or Size 8 8
Device Damaged Prior to Use 3 3
Inflation Problem 3 3
Device Difficult to Setup or Prepare 2 2
Pressure Problem 2 2
Appropriate Term/Code Not Available 1 1
Break 1 1
Leak/Splash 1 1
Crack 1 1
Deflation Problem 1 1
Gradient Increase 1 1
Application Program Problem 1 1
Difficult to Advance 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 87 87
Perforation of Esophagus 10 10
Perforation 6 6
No Consequences Or Impact To Patient 5 5
Insufficient Information 4 4
Unintended Radiation Exposure 2 2
Chest Pain 2 2
Hemorrhage/Bleeding 1 1
Pneumothorax 1 1
No Code Available 1 1
Syncope/Fainting 1 1
Asystole 1 1
Laceration(s) of Esophagus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LLC II Jun-07-2024
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