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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pediatric esophageal atresia anastomosis device
Regulation Description Gastrointestinal tube and accessories.
Definition Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter.
Product CodePTK
Regulation Number 876.5980
Device Class 3

MDR Year MDR Reports MDR Events
2021 13 13
2022 8 8
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 10 10
Failure to Advance 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Align 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Stenosis of the esophagus 9 9
Failure to Anastomose 6 6
Fistula 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Wheezing 1 1
Perforation of Esophagus 1 1
Laceration(s) of Esophagus 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Pneumonia 1 1
Hyperventilation 1 1
Respiratory Insufficiency 1 1
Bronchitis 1 1

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