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

Model Number	G47283
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) of Esophagus (2398); Perforation of Esophagus (2399)
Type of Reportable Event	Serious Injury
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.The ifu states, "potential complications during the device indwelling period also include perforation/leak of one or both esophageal pouches or anastomotic site, which could result in additional procedures and/or death." prior to distribution, all flourish pediatric esophageal atresia devices are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.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
A pediatric patient with congential pediatric esophageal atresia underwent placement of a cook flourish pediatric esophageal atresia device.Successful anastomosis was achieved.Dilation of the anastomosis was performed (see mdr 1037905-2021-00613).At 53 days post-placement, an esophageal leak was suspected at the anastomotic site.The site noted, ¿even though there was no demonstrated leak on the esophagogram she continued to have a clinical esophageal leak with saliva draining from her chest tube.This was a clinical leak that needed to be treated and since she didn¿t have any recent esophageal surgery except for the magnet placement and this began after magnet placement this was considered to be from the device.¿ the site also noted, ¿had a leak from upper pouch and multiple surgeries but concern was that magnets didn't come together end to end and possibly side to side possibly related leak.¿ it was also noted, by the site, that the event did not lead to a serious injury or illness.Treatment included, as noted by the site, ¿interventional radiology placement of drainage into loculated posterolateral apical hydropneumothorax.Drain set to bulb suction.¿.
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.The ifu states, "potential complications during the device indwelling period also include perforation/leak of one or both esophageal pouches or anastomotic site, which could result in additional procedures and/or death." prior to distribution, all flourish pediatric esophageal atresia devices are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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.The following information was corrected: annex a coding and the corrective action statement.

• 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: 13018904
• Report Number: 1037905-2021-00694
• Device Sequence Number: 5188371
• 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
• PMA/510(K) Number: H150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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: 11/18/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 09/15/2022
• 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