MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA FLRSH-PEA manufactured by Cook Endoscopy.
[135167514]
Common device name: 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. 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
[135167515]
The physician used a cook flourish pediatric esophageal atresia device on a pediatric patient with esophageal atresia. The following was reported: on (b)(6) 2018 the flourish pediatric esophageal atresia device was placed with the patient under general anesthesia. The length of the esophageal gap was 2. 0 cm. At completion of the procedure, the flourish magnets were in the distal most portion of the esophageal ends. On (b)(6) 2018 it was reported that the magnets were unable to make any approach of the esophageal pouches despite many maneuvers. The following was received 31-dec-2018 from cook product management: this is the patient that we found one of the magnets (oral catheter) to be loose before placing it in the patient. We ended up opening another flourish device and using the oral catheter from the second device to finish the case. I [cook product manager] recently found out that the procedure was unsuccessful on (b)(6) 2018. I asked if the physician saved the magnets but have not gotten a response. The patient was 9 weeks old. The following was received 09-jan-2019 from cook product management: there is no device to return as it was discarded over the holidays. On 9-jan-2019, the study investigator provided the following response regarding the circumstances of the failed anastomosis: "the magnets were repositioned three (3) times (once moved from mouth to nares [nostrils] ) due to migration of ends of magnets further apart. Upon repositioning, they got to two (2) cm of ends together but then migrated further again, and decision was made to remove the magnets as they were not making progress after twelve (12) days. The flourish device was removed on (b)(6) 2018. On (b)(6) 2019, the study investigator reported that the patient remains in the study, awaiting surgical closure of the esophageal atresia. The following was received on 16-jan-2019 from cook product management: [the patient] is having cardiac issues and there is no plan of doing something with the esophagus in the near future. They are considering giving the magnets a new try before the surgery. An unintended section of the device did not remain inside the patient? S body. The patient will require repair of the pre-existing atresia, since the anastomosis was not achieved. Surgical repair is not planned at the time of this report, and additional attempts to achieve anastomosis with the flourish device are under consideration. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2019-00024 |
| MDR Report Key | 8262133 |
| Date Received | 2019-01-18 |
| Date of Report | 2018-12-24 |
| Date of Event | 2018-12-24 |
| Date Mfgr Received | 2018-12-24 |
| Device Manufacturer Date | 2018-07-12 |
| Date Added to Maude | 2019-01-18 |
| 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 | 2019-01-18 |
| Catalog Number | FLRSH-PEA |
| Lot Number | W4091548 |
| Device Expiration Date | 2019-07-12 |
| 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 | 2019-01-18 |