MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA FLRSH-PEA manufactured by Cook Endoscopy.
[141025301]
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. 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.
Patient Sequence No: 1, Text Type: N, H10
[141025302]
The physician used a cook flourish pediatric esophageal atresia device on a pediatric patient with esophageal atresia. The following was reported: the patient fell within the 4 cm parameter (3. 8-4 cm) [atretic gap length] and the flourish device was placed on (b)(6) 2019. On (b)(6) 2019, it was reported to cook that the magnets did not move closer [together] and were removed on (b)(6) 2019. The magnets did not work [failure to achieve anastomosis]. The patient was reported to be doing "okay. " a section of the device did not remain inside the patient? S body. It is unknown if the patient underwent surgery post-flourish removal to repair the atretic gap. 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 | 1037905-2019-00087 |
| MDR Report Key | 8363451 |
| Date Received | 2019-02-22 |
| Date of Report | 2019-01-28 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2018-07-12 |
| Date Added to Maude | 2019-02-22 |
| 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 | 2019-02-22 |
| 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 | 2019-02-22 |