MAUDE Adverse Event Report: COOK ENDOSCOPY 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	Failure to Anastomose (1028)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: ptk- tube, gastrointestinal (and accessories).Investigation evaluation: the customer provided two pictures.The first picture is of the day the magnets were placed.The magnets can be seen pointing away from each other, the distance is not specified.The second picture is the day the magnets were removed from the patient.The magnets seem to be in the same position, facing away from each other.The pictures do not provide any scaling for distance to be concluded between the magnets.Our laboratory evaluation of the product said to be involved could not confirm any device defects which could cause the device to not form an anastomosis.The device was returned with the oral catheter cut at 21 cm.The oral magnet was still attached to the inner catheter.The rest of the device was intact.The magnets were attracting when placed in proximity to each other, this confirms correct polarity.A visual inspection showed both magnets had a reddish brown substance all over the surface.There was some yellow/white substance on the feed meds port, indicating it was used.A dimensional inspection was performed on the magnets.The magnets were measured for length and outer diameter and found to be within specification.Confirmation of the magnet size and material (via certification review) supports the magnets are the correct strength.A product specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.The internal quality check (iqc) records for the magnets were also reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.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.
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: flourish device was successfully placed on (b)(6) 2021.During indwelling time the magnets did not progress or moved.On (b)(6) 2021 the surgeon decided to remove the magnets.A section of the device did not remain inside the patient¿s body.The patient will require the surgical approach to treat the esophageal atresia.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Continued from section d2: ptk- tube, gastrointestinal (and accessories.Investigations evaluation: the customer provided two pictures.The first picture is of the day the magnets were placed.The magnets can be seen pointing away from each other, the distance is not specified.The second picture is the day the magnets were removed from the patient.The magnets seem to be in the same position, facing away from each other.The pictures do not provide any scaling for distance to be concluded between the magnets.Our laboratory evaluation of the product said to be involved could not confirm any device defects which could cause the device to not form an anastomosis.The device was returned with the oral catheter cut at 21 cm.The oral magnet was still attached to the inner catheter.The rest of the device was intact.The magnets were attracting when placed in proximity to each other, this confirms correct polarity.A visual inspection showed both magnets had a reddish brown substance all over the surface.There was some yellow/white substance on the feed meds port, indicating it was used.A dimensional inspection was performed on the magnets.The magnets were measured for length and outer diameter and found to be within specification.Confirmation of the magnet size and material (via certification review) supports the magnets are the correct strength.A product specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.The internal quality check (iqc) records for the magnets (were also reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.An unused device from lot number w4436901 was returned.A visual inspection did not show any damage or defects to the device, none of the components were missing.The magnets were attracting when placed in proximity to each other, this confirms correct polarity.A dimensional inspection was performed on the magnets.The magnets were measured for length and outer diameter and found to be within specification.Confirmation of the magnet size and material (via certification review) supports the magnets are the correct strength.A product specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.The iqc records for the magnets were also reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.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): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12193193
• Report Number: 1037905-2021-00326
• Device Sequence Number: 17041701
• Product Code: PTK
• UDI-Device Identifier: 10827002472836
• UDI-Public: (01)10827002472836(17)220406(10)W4457428
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2022
• Device Model Number: G47283
• Device Catalogue Number: FLRSH-PEA
• Device Lot Number: W4457428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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: GASTROSCOPE, UNKNOWN OR MODEL; GASTROSCOPE, UNKNOWN OR MODEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 DA
• Patient Weight: 6