MAUDE Adverse Event Report: COOK ENDOSCOPY FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA; PTK PEDIATRIC ESOPHAGEAL ATRESIA ANASTOMOSIS DEVICE

Model Number	G47283
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Stenosis of the esophagus (4487); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with pre-existing congenital esophageal atresia underwent placement of a cook flourish esophageal atresia device.When the patient was (b)(6), the flourish¿ pediatric esophageal atresia device was placed with the patient under general anesthesia.At the completion of the procedure, the magnets were in the distal most portion of the esophageal ends.The resulting gap measured 2.2 cm.No additional procedures were performed.Anastomosis was achieved and the flourish device was removed 30 days post-placement.The first dilation for stenosis at the anastomotic site occurred 101 days after removal of the flourish device [subject of report].A section of the device did not remain in the patient.The patient experienced a stricture at the anastomosis site which required dilation.There were no adverse effects reported.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the ifu states the following: "based on limited clinical data on this device, the rate of endoscopic dilation or surgical intervention for stenosis of the anastomosis is higher than that following surgery." the report indicated: "the patient underwent esophageal dilation for stricture at the anastomotic site." overall clinical success, anastomosis, was achieved with the use of the flourish pediatric esophageal atresia device.Prior to distribution, all flourish pediatric esophageal atresia devices are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA
• Common Device Name: PTK PEDIATRIC ESOPHAGEAL ATRESIA ANASTOMOSIS DEVICE
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12786918
• Report Number: 1037905-2021-00613
• Device Sequence Number: 14741423
• Product Code: PTK
• UDI-Device Identifier: 10827002472836
• UDI-Public: (01)10827002472836(17)200531(10)W4221406
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: G47283
• Device Catalogue Number: FLRSH-PEA
• Device Lot Number: W4221406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female