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 145076V2 manufactured by Pfm Medical Ag.
[137536131]
"he" device history record (dhr) has been reviewed and showed no deviations. The information you provided was used to conduct an investigation. First, a drop test was carried out with the result of 23. 76 n. The coil was fine. In the interim review an ejection force of 25. 2 n was measured. The images of the included recordings show the coil in the defect. In the angiography a complete occlusion was recognized. Nevertheless, the user replaced the coil again, with the result that the coil dissolved. A corrective action is not necessary because the error has not been caused by the product or procedure.
Patient Sequence No: 1, Text Type: N, H10
[137536132]
The coil separated from the delivery system while in the catheter. It was retrieved without incident. Physician configured coil in the descending aorta, pulled system back into defect, suspected potential coarc and decided to retrieve / re-configure. Upon sheath re-entry, coil detached from mandrel wire. A 5x4 ado i was used to complete the procedure. Physician did not notice high resistance during forwarding or retrieval of the system into the implantation catheter. Curvature of the implantation catheter in the vessel was mild. The physician did not notice a gap between the pusher and coil prior to release. The physician did not move the rotation screw forward at all. In the film, a gap is noticeable between the pusher wire and the device; approximately 1cm or more.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032582-2016-00009 |
| MDR Report Key | 8313083 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-02-25 |
| Device Manufacturer Date | 2014-08-01 |
| 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 | 145076V2 |
| Catalog Number | 145076V2 |
| Lot Number | 1014444.01 |
| Device Expiration Date | 2017-08-31 |
| 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 |