MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-29 for FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA G47283 FLRSH-PEA manufactured by Cook Endoscopy.
[140352713]
Common device name, procode: 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 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 instructions for use warns, "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. " the report indicated: "the patient underwent esophageal dilation for a stricture at the anastomotic site. " overall clinical success, anastomosis, was achieved with the use of the flourish pediatric esophageal atresia device. 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 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.
Patient Sequence No: 1, Text Type: N, H10
[140352714]
The physician used a cook flourish pediatric esophageal atresia device on a pediatric patient with esophageal atresia. The following was reported: "on (b)(6) 2019 the flourish pediatric esophageal atresia device was placed with the patient under general anesthesia. The length of the esophageal gap was 1. 0 cm. At completion of the procedure, the flourish magnets were in the distal most portion of the esophageal ends. Additional procedure included,? Dilation of gastroesophageal junction (gej) with balloon due to stricture [unrelated to flourish device]. " on (b)(6) 2019 (4 days post-placement of flourish device), anastomosis was considered achieved with esophagram showing connected flow of contrast agent [between upper and lower esophageal ends]. On (b)(6) 2019 (6 days post-placement), the flourish device was removed. On (b)(6) 2019 (13 days post-placement and 7 days-post removal), the patient underwent esophageal dilation for stricture at the anastomotic site [subject of this report]. The patient remains in the study. " a section of the device did not remain inside the patient? S body. The patient required dilation due to a stricture of the anastomosed site. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2019-00159 |
| MDR Report Key | 8465709 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-03-06 |
| Device Manufacturer Date | 2018-07-12 |
| Date Added to Maude | 2019-03-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SCOTTIE FARIOLE |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | COOK ENDOSCOPY |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA |
| Product Code | PTK |
| Date Received | 2019-03-29 |
| Model Number | G47283 |
| Catalog Number | FLRSH-PEA |
| Lot Number | W4091548 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-29 |