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

Model Number	G47283
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Insufficient Information (4580)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with pre-existing esophageal atresia had a flourish device placed in 2020.Anastomosis was achieved with the flourish device.The following information was received regarding this patient's outcome: "patient with complications after flourish magnamosis (placed in rush - chicago) a few years ago [2020].The patient developed a chronic anastomotic leak [captured in 1037905-2021-00694] and recurrent tef.We operated on her this friday, and it almost seemed like the magnets had created the esophageal anastomosis through the lung tissue.We treated for a chronic esophageal anastomotic leak [previously captured in 1037905-2021-00694] and a recurrent tef.We did a neck dissection, redo of right thoracotomy, drainage of empyema/decortication, resection of esophageal stricture with primary anastomosis, repair of recurrent tef, posterior tracheopexy".Further information is requested and will be provided in a follow up report.
Additional Manufacturer Narrative
This event is under investigation and a follow up report will be provided.
Event or Problem Description
A patient with pre-existing esophageal atresia had a flourish device placed in 2020.Anastomosis was achieved with the flourish device.The following information was received regarding this patient's outcome: "patient with complications after flourish magnamosis (placed in rush - chicago) a few years ago [2020].The patient developed a chronic anastomotic leak [captured in 1037905-2021-00694] and recurrent tef.We operated on her this friday, and it almost seemed like the magnets had created the esophageal anastomosis through the lung tissue.We treated for a chronic esophageal anastomotic leak [previously captured in 1037905-2021-00694] and a recurrent tef.We did a neck dissection, redo of right thoracotomy, drainage of empyema/decortication, resection of esophageal stricture with primary anastomosis, repair of recurrent tef, posterior tracheopexy." the following was received on 04/28/2023: per the treating physician: the flourish created the esophageal magnamosis through the upper lobe of the lung.The surgery performed (b)(6) 2023 repaired the recurrent tef.The surgeon feels the tef was there all along before flourish was used.The surgery was to repair everything [pre-existing conditions and flrsh outcomes].The tef was pre-existing.There was a recurrent fistula and a leak "probably since flourish anastomosis was obtained.".
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 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: based on the information provided the patient was diagnosed with a recurrent tracheoesophageal fistula.The complication reported is a known clinical complication.The user indicated the cause of the recurrent tracheoesophageal fistula was possibly related to both the flourish device and the procedure.There is no evidence to suggest the report is due to a device failure.The ifu states, "potential complications during the device indwelling period include inability to approximate the atretic gap with the magnets, rupture of the balloon in the gastrostomy device; ulceration, tissue irritation, or necrotizing fasciitis around the stoma; trauma to the patient's gum due to the constant catheter pressure, new or recurrent tracheoesophageal fistula, inflammation, and bleeding." 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: 16816007
• Report Number: 1037905-2023-00188
• Device Sequence Number: 14876736
• Product Code: PTK
• UDI-Device Identifier: 10827002472836
• UDI-Public: (01)10827002472836(17)200531(10)W4221406
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: H150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: 04/02/2023
• Supplement Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/22/2023
• 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 Age: 3 YR
• Patient Sex: Female