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	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
Flourish post-approval study 17-09; pt # (b)(6).At 3 days from birth, the patient underwent thoracotomy for repair of the tef.At 405 days from birth the patient underwent rigid bronchoscopy, flexible esophagoscopy and esophageal dilation.At 453 days of age, the flourish pediatric esophageal atresia device was placed with the patient under general anesthesia.A resulting gap measurement (following placement) was not provided.No additional procedures were reported.Six days after placement (459 days of age), anastomosis was achieved and the flourish magnets were removed.Method of confirmation of anastomosis was not provided.The first dilation of stricture at the anastomotic site occurred 12 days following device removal.The patient underwent subsequent dilation 24, 35, 64, 113, and 246 days following device removal.
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 report indicated the patient was treated for stricture at the anastomotic site.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." prior to distribution, all flourish pediatric esophageal atresia devices are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: based on the quality engineering risk assessment, no corrective action is warranted at this time.Quality assurance will continue to monitor for complaint trends.

• 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: 15165616
• Report Number: 1037905-2022-00451
• Device Sequence Number: 11279659
• Product Code: PTK
• UDI-Device Identifier: 10827002472836
• UDI-Public: (01)10827002472836(17)200531(10)W4221406
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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 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: 07/13/2022
• Initial Report FDA Received Date: 08/04/2022
• 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: Male