MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA G47283 FLRSH-PEA manufactured by Cook Endoscopy.
[142673174]
Information regarding suspect medical device: product code: ptk. Common device name: tube, gastrointestinal (and accessories). Investigation evaluation: 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. A visual inspection showed the oral catheter had a very dark spot along the catheter. There were some white spots on the back of the oral catheter magnet. It looked like the magnet coating had been worn down. Some of the number markings on the gastric catheter were smudged. There was some yellow substance on the feed meds port, indicating that 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. The magnet strength was evaluated and found to be acceptable. 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. 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.
Patient Sequence No: 1, Text Type: N, H10
[142673175]
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 prior to device placement has not been provided [slightly less than 4 cm per cook product manager]. At completion of the procedure, the flourish magnets were in the distal most portion of the esophageal ends. Per operative report dated (b)(6) 2019: the magnetic ends of the flourish device were unable to detect each other [failure to achieve anastomosis]. The flourish was removed. The following was noted in the operative report per the physician:? We proceeded to the operating room today with hopes of mobilizing each end of the esophagus to bring them closer together such that the magnets would be able to detect each other and provide sequential advancement of the esophageal ends. The esophagus was found to share a common wall with the trachea. Sharp dissection of the common wall was attempted. The proximal esophageal pouch was noted to be very high in the mediastinum and full dissection from the trachea was not achieved. The distal esophageal segment was found to be short as viewed through the chest (thoracotomy), 'perhaps 1 cm. ' traction sutures were placed on the ends of both esophageal pouches. " per cook product manager after conferring with the physician, this is a much less invasive procedure than atresia repair and was done because the trachea shared a wall with the esophagus. This was done to 'mobilize the esophagus' and will aid in future motility for the patient once the atresia is fixed [not device related]. It was reported that the facility is going to wait a few weeks for the esophageal mobilization to heal, then will consider placing a second flourish device in the patient. A section of the device did not remain inside the patient? S body. Surgery to repair the atresia has not yet been performed. 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 | 1037905-2019-00142 |
| MDR Report Key | 8432771 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2018-07-12 |
| Date Added to Maude | 2019-03-19 |
| 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 | 0 |
| Brand Name | FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA |
| Product Code | PTK |
| Date Received | 2019-03-19 |
| Returned To Mfg | 2019-02-27 |
| Model Number | G47283 |
| Catalog Number | FLRSH-PEA |
| Lot Number | W4091548 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-19 |