MAUDE Adverse Event Report: COOK ENDOSCOPY FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA

Model Number	G47283
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ptk- tube, gastrointestinal (and accessories).A follow up report will be submitted with the completed investigation.
Event or Problem Description
The physician used a cook flourish pediatric esophageal atresia device on a pediatric patient with esophageal atresia.The following was reported.Flourish device was successfully placed on (b)(6) 2020.During indwelling time the magnets did not progress/move [failure to achieve anastomosis].On (b)(6) 2020 the surgeon decided to remove the magnets.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Section d2: ptk- tube, gastrointestinal (and accessories).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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.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.
Event or Problem Description
The following was originally reported: the physician used a cook flourish pediatric esophageal atresia device on a pediatric patient with esophageal atresia.The following was reported flourish device was successfully placed on (b)(6) 2020.During indwelling time the magnets did not progress/move [failure to achieve anastomosis].On (b)(6) 2020 the surgeon decided to remove the magnets.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." the following was received on 02/07/2022: this patient is now in the post approval study.The patient underwent distal tef ligation occurred at two days of age; proximal tef ligation and tracheostomy occurred at 44 days of age.The initial (untreated) gap measurement was not provided.When the patient was 121 days of age, 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 measurement was not provided.Anastomosis was not achieved [subject of report].The magnets ¿did not appose the two ends of the esophagus as expected.¿ the date of flourish device removal was not provided.The site has been queried for this information.Additional surgical intervention was provided to close the pre-existing esophageal gap.

• Brand Name: FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA
• 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: 11931372
• Report Number: 1037905-2021-00233
• Device Sequence Number: 14375792
• Product Code: PTK
• UDI-Device Identifier: 10827002472836
• UDI-Public: (01)10827002472836(17)210709(10)W4363253
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G47283
• Device Catalogue Number: FLRSH-PEA
• Device Lot Number: W4363253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 06/03/2021; 02/07/2022
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/28/2021; 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male
• Patient Weight: 4 KG