MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-04 for ENDOFLIP EF-325N manufactured by Crospon Ltd.
[137716245]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[137716246]
According to the reporter, the catheter was placed without a scope and the tip of the catheter went in to the cut in the esophagus when they did the poem procedure (peroral endoscopic myotomy). The physician performed an endoflip procedure, then performed a poem procedure. It was noted that this was the first poem procedure performed by the physician. Then, the physician passed the scope to examine the esophagus, and closed the mucosotomy with clips at 32cm. The scope was removed and placed the catheter again, blind. The physician experienced some tightness and did not see the gastroesophageal junction on the monitor. The flip was repositioned and experienced some resistance, so the physician removed the catheter and replaced the scope. That? S when the physician found a mucosal tear at 42cm, and due to the myotomy performed, the tear was full thickness into the peritoneal cavity. The mucosal tear was closed with clips. The patient was then kept npo (nothing by mouth) and had an antibiotic for a few days, and slowly advanced to clear liquid diet. The patient underwent a barium swallow on post-procedure day 3 which did not show a leak but did show slow emptying into the stomach. On post-procedure day 4, the patient had symptomatic bradycardia and had to get a pacemaker. The patient underwent a ct scan to see if there were any hematomas or collections around the esophagus that could have been impinging on the heart, but the ct scan was normal. The patient went home in stable condition on post-procedure day 8. The physician felt like the soft tip of the cathet er was too flexible, that it actually bent and allowed the more rigid catheter to lead, which was a risk for perforation. The physician was trained to place the catheter blind, which was the recommendation and was advised to follow the catheter with the scope in unique cases, like poem procedures, where mucosotomies and myotomies have been performed and weakens the structure of the esophagus. The physician stated that will now follow the catheter with the scope and place it under direct vision for all future poems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006897778-2019-00002 |
| MDR Report Key | 8386950 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-04 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2019-03-04 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | CROSPON LTD |
| Manufacturer Street | GALWAY BUSINESS PARK, DANGAN |
| Manufacturer City | GALWAY,FL H91P2DK |
| Manufacturer Postal Code | H91P2DK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOFLIP |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2019-03-04 |
| Model Number | EF-325N |
| Catalog Number | EF-325N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSPON LTD |
| Manufacturer Address | GALWAY BUSINESS PARK, DANGAN GALWAY,FL H91P2DK H91P2DK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-04 |