MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-06 for NIT-OCCLUD PDA 145096V2 manufactured by Pfm Medical Ag.
[136291199]
The information provided was used to conduct an investigation. It was reported that the coil jumped forward during the configuration and got stuck in the aorta. The coil was badly positioned with a few windings in the pda. It was also reported that the coil jumped in the pda. It was also reported that there was no resistance or gap noticed before releasing the coil. A gap is not present during releasing. According to the user the rotating square was not pressed, even though the safety clip was removed. The coil was retrieved with a snare and the defect was closed with an amplatzer device. During the inspection in the production an ejection force of 24. 2 n was measured. The already deformed coil was reassembled and a new drop test was performed. The results here was 19. 8 n. A corrective action is not necessary because the error has been evaluated in the risk analysis and is classified as acceptable. This complaint is unjustified.
Patient Sequence No: 1, Text Type: N, H10
[136291200]
Premature deployment. Physician was positioning the nit-occlude in the pda when the device, "popped off. " the device jumped forward but not completely into the aorta. Physician was able to snare the device out and placed an amplatzer device. The curvature of implantation catheter in the vessel was mild. The physician did not notice a gap between pusher and coil prior to release. The physician did not move the rotation screw forward at all. When the device deployed on its own, it jumped forward and was poorly positioned in the pda with many coil hanging out into the aorta.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032582-2016-00007 |
| MDR Report Key | 8313046 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2016-02-15 |
| Date Mfgr Received | 2016-02-15 |
| Date Added to Maude | 2019-02-06 |
| 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 | MR. TROY TAYLOR |
| Manufacturer Street | 1916 PALOMAR OAKS WAY SUITE 150 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer G1 | PFM MEDICAL AG |
| Manufacturer Street | WANKELSTRASSE 60 |
| Manufacturer City | K 50996 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 50996 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIT-OCCLUD PDA |
| Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
| Product Code | MAE |
| Date Received | 2019-02-06 |
| Model Number | 145096V2 |
| Catalog Number | 145096V2 |
| Lot Number | 1013937.02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFM MEDICAL AG |
| Manufacturer Address | WANKELSTRASSE 60 K?LN, NORDRHEIN-WESTFALEN 50996 GM 50996 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-06 |