MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-12-13 for FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA FLRSH-PEA manufactured by Cook Endoscopy.
[130536882]
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: the root cause is abnormal use. The device was used in a patient with an atretic segment greater than 4 cm apart. However, we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. The instructions for use states the following indications for use, "this device is indicated for atretic segments < 4 cm apart. " the instructions for use states the following contraindication, "for atretic segments > 4 cm apart. " 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. Additional comments regarding this report: based on the information provided that the device was used on a contraindicated patient, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Patient Sequence No: 1, Text Type: N, H10
[130536883]
The physician used a cook flourish pediatric esophageal atresia device on a pediatric patient with esophageal atresia. The following was reported: it was reported on (b)(6) 2018 that there was failure of the device to achieve anastomosis. On (b)(6) 2018, the flourish? Device was placed. At the time of the study procedure, the atretic gap was determined to be greater than 4 cm. The device was placed. The following was noted,? Removed magnets after a few days, as expected there was no movement on x-ray.? Operative repair of the esophageal atresia was done on (b)(6) 2018. Initial imaging review to confirm the gap measurement was done prior to irb approval. Once the flourish was in place and imaging was done to confirm the placement of the magnets, it was noted the gap was greater than 4 centimeters. The following was determined on (b)(6) 2018: the physician had a difficult time placing the distal magnet due to the location of the original stoma and patient anatomy (infant patient). The patient's lower pouch was unusually oriented. On the second day of the magnets being placed, the physician repositioned the magnets and the gap appeared to be 3. 2 cm after repositioning. The following was reported on (b)(6) 2018: this patient presented with a type c esophageal atresia [esophageal atresia with a tracheoesophageal fistula (tef) on the lower segment]. The tef was previously repaired on (b)(6) 2018. The initial gap had been previously measured at 4 cm. The method of confirmation was noted as follows,? Gap study, using clip on distal esophagus, and oe tube [oral-esophageal tube] and contrast in proximal pouch.? On (b)(6) 2018 fistula ligation was completed and a gap study showed the resulting gap at 3. 9 cm. On (b)(6) 2018 the patient underwent placement of the flourish device, as previously noted. After placement, the gap measured greater than 4 cm. On (b)(6) 2018 the flourish device was removed. Anastomosis was not achieved. To the question,? If no anastomosis was achieved, specify the circumstances surrounding failed anastomosis? , the site provided the following:? Gap was greater than 4 cm.? On (b)(6) 2018 the patient underwent thoracotomy with repair of the esophageal atresia. The patient exited the study on the same day. An unintended section of the device did not remain inside the patient? S body. The patient required surgery to correct the pre-existing atresia, since the anastomosis was not achieved. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence and is reported to be "okay. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2018-00589 |
| MDR Report Key | 8161432 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2018-07-12 |
| Date Added to Maude | 2018-12-13 |
| 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 | 2018-12-13 |
| Catalog Number | FLRSH-PEA |
| Lot Number | W4091548 |
| Device Expiration Date | 2019-07-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-12-13 |