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.
[135384966]
The device history record (dhr) has been reviewed and showed no deviations. The information you provided was used to conduct an investigation. The investigation showed that the safety clip was not removed and the release mechanism was not engaged. Thus, the reason for rejection can be confirmed. On the supplied x-ray it seems that the coil is separated from the carrier. Furthermore, it can be seen that two windings are released, then several angiographs were taken and then even the coil sits in position. The configuration of the coil between two redundant windings and the coil in its final position is not visible on the film. The exact reason why it came to this complaint cannot be recognized. A corrective action is not necessary because the error has been evaluated in the risk analysis and is classified as acceptable. The complaint is justified.
Patient Sequence No: 1, Text Type: N, H10
[135384967]
The coil was not attached. Upon deployment, the coil curled through the pigtail catheter. When physician tried to resheath, it was discovered that the coil was not attached. Only about 1 third of the coil was out. There was no problem during the prep or insertion of the device into the catheter. The nit-occlud did move to the proper positions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032582-2016-00006 |
| MDR Report Key | 8313017 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2015-11-04 |
| Date Mfgr Received | 2016-01-28 |
| 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 Phone | 7607588749 |
| 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 | 1014647.01 |
| 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 |