MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-02-05 for NIT-OCCLUD PDA 145096V2 manufactured by Pfm Medical Ag.
[137430670]
The device history record (dhr) has been reviewed and showed no deviations. Thus, the nit-occlud system meets our specifications. This also shows that the procedure (positioning and releasing) was done without complications. The choice of the dimensioning of the occluder could have led to an anchorage with 1-2 turns on the pulmonary side which was not performed by the physician. There were no samples, film or image material available for a fault investigation. Only the description of the doctor was provided. In addition, the production documents have no deviations. Therefore, no qualified statement can be made by the manufacturer. The cause of the error cannot be determined. The physician stated that "it was a pda morphology issue. " it is pointed out that the complained samples and if possible also film or picture material are necessarily made available in order to carry out a proper complaint processing.
Patient Sequence No: 1, Text Type: N, H10
[137430671]
The nit-occlud was successfully implanted. After implantation, the physician waited and within 10 minutes, the product dislodged and migrated to the dao. Physician was able to snare the nit-occlud and retrieve it successfully, with no harm to the patient. Physician successfully implanted an amplatz duct occluder to complete the procedure. Physician was treating a type a pda. Patient age: (b)(6) yrs. Weight: (b)(6) kg. Measured ductus size (mm) - aortic: 9. 3, pulmonary: 1. 6, length 7. 6. Procedure duration: 139 minutes. Pda access was both venous and aortal. A 6fr introducer sheath was used. Heparin (systemic): 1800 iu/kg. One flushing. It is unknown how many revolutions the physician moved the rotation screw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032582-2017-00011 |
| MDR Report Key | 8308707 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-02-05 |
| Date of Report | 2017-02-05 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2017-12-20 |
| Device Manufacturer Date | 2016-03-07 |
| Date Added to Maude | 2019-02-05 |
| 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 MEPRO GMBH |
| Manufacturer Street | AM SOTERBERG 4 |
| Manufacturer City | 66620 NONNWEILER, GM |
| Manufacturer Country | GM |
| 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 | 2019-02-05 |
| Model Number | 145096V2 |
| Catalog Number | 145096V2 |
| Lot Number | 1018865 |
| Device Expiration Date | 2019-03-07 |
| 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. Required No Informationntervention | 2019-02-05 |