MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-25 for NIT-OCCLUD PDA 145076 manufactured by Pfm Medical Ag.
[139183601]
There was no effect on the patient. It cannot be excluded that a product defect exists.
Patient Sequence No: 1, Text Type: N, H10
[139183602]
The proximal loop of the coil was fractured positioning the device on the defect. The device was placed on the defect. It was not necessary to remove it. Removing it could have led to complications due to the dimensions of the patient. There was a potential risk of embolization. This even occured in argentina using a product that is similarto one marketed in the us (ref (b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005704822-2019-00001 |
| MDR Report Key | 8367488 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-02-25 |
| 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 | PDA OCCLUDER |
| Product Code | MAE |
| Date Received | 2019-02-25 |
| Model Number | 145076 |
| Catalog Number | 145076 |
| Lot Number | 1024829 |
| 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 | 2019-02-25 |