MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA; PTK PEDIATRIC ESOPHAGEAL ATRESIA ANASTOMOSIS DEVICE

Model Number	G47283
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pediatric patient with pre-existing esophageal atresia, underwent placement of the cook flourish pediatric esophageal atresia device.Prior to placement, the surgeon performed a thoracoscopic mobilization of the esophageal ends, to attempt a primary thoracoscopic anastomosis.Despite mobilization.There was still a gap of 4.0 cm once the lower pouch was mobilized, and no extra length was gained to improve stability of lower magnet prior to placement.Lower anastomotic pouch was 1 cm above diaphragm.The flourish magnets never moved closer together over course of 8 days and they were removed through the same orifice as they were placed [failure to achieve anastomosis].There was no leak on to esophogram.No adverse events were experienced.This patient was not in the flourish post-approval study.
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: we could not conduct a complete investigation, because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.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): WILSON-COOK MEDICAL INC; 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: 16897096
• Report Number: 1037905-2023-00211
• Device Sequence Number: 5956152
• Product Code: PTK
• UDI-Device Identifier: 10827002472836
• UDI-Public: (01)10827002472836(17)230920(10)W4638147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: H150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: G47283
• Device Catalogue Number: FLRSH-PEA
• Device Lot Number: W4638147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 6 MO
• Patient Sex: Male