MAUDE Adverse Event Report: COOK ENDOSCOPY FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA

Model Number	G47283
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 customer included an image showing the atretic gap measurement that was done before inserting the device.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: 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
The physician used a cook flourish pediatric esophageal atresia device on a pediatric patient with esophageal atresia.The following was reported from a cook representative.The flourish device was introduced on (b)(6) 2020.Magnets were repositioned post-operation in radiology as the distal magnet seemed to have fallen out of place, likely during patient transport and/or patient handling.Both magnets were well-aligned following repositioning.Even though the oral magnet seemed a bit kinked at first, possibly due to the manner in which the outer catheter was fixed onto the baby¿s cheek, it later showed to have advanced and straightened out.During the whole time the magnets were in place, the upper magnet was left unlocked (except when patient was moved), the lower magnet was kept locked and the gastric catheter (feeding tube) remained in the distal pouch.The magnets remained well-aligned and showed good progression; the gap having been reduced to 2.2 cm by monday (day 3).On monday, the distal magnet also started showing some progression, as it had moved a bit upwards and out of the outer gastric catheter.On day 4 ((b)(6)2020), the patient started to have a fever.Imaging showed that the distal magnet had a deviated trajectory, having moved cephalic and lateral, to the patient¿s right.Contrast study showed some drainage back into the stomach however it also showed contrast draining and collecting into the right bronchus, likely indicating perforation of distal pouch.This prompted the physician to remove both magnets without further incident.A chest tube was placed, and a small amount of fluid was drained.A thoracotomy will likely to be performed next to assess further.An unintended section of the device did not remain inside the patient¿s body.A chest tube was placed and a thoracotomy will likely to be performed next to assess further.

• Brand Name: FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10586114
• Report Number: 1037905-2020-00407
• Device Sequence Number: 2627486
• Product Code: PTK
• UDI-Device Identifier: 10827002472836
• UDI-Public: (01)10827002472836(17)210709(10)W4363253
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 07/09/2021
• Device Model Number: G47283
• Device Catalogue Number: FLRSH-PEA
• Device Lot Number: W4363253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 WIRE GUIDE UNKNOWN MAKE OR MODEL
• Outcome Attributed to Adverse Event: Required Intervention