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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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 12 12
Adverse Event Without Identified Device or Use Problem 7 7
Inflation Problem 2 2
Product Quality Problem 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult to Advance 1 1
Material Twisted/Bent 1 1
Appropriate Term/Code Not Available 1 1
Crack 1 1
Deflation Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
No Consequences Or Impact To Patient 5 5
Perforation of Esophagus 5 5
Perforation 3 3
Unintended Radiation Exposure 2 2
Hemorrhage/Bleeding 1 1
No Code Available 1 1
Syncope/Fainting 1 1
Asystole 1 1

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