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.
[137015601]
The device history record (dhr) has been reviewed and showed no deviations. The information you provided was used to conduct an investigation. It was reported that the system was not controlled prior to the application - whether the coil was connected to the carrier. No high resistance was noted when the coil was advanced. After the coil was in a good position it released itself without actuating the dropping. The coil was stable and the shunt decreased after 12 minutes. The complaint was confirmed by the accompanying video. The investigation of the carrier system could not provide information about the reason for the complaint. The gap was with 4 mm within the specification, as well as the discharge part of the carrier. The safety split pin was still mounted. A corrective action for the error identification and correction will be initiated. This complaint is justified.
Patient Sequence No: 1, Text Type: N, H10
[137015602]
Physician reported an awful premature release. Physician forgot to check that the device was attached to the cable, when the pda coil (last loop) was deployed, the device released. It did release in a good position, was stable, and the shunt diminished to trivial with resolution of the murmur in 12 minutes. The physician did not notice high resistance during forwarding of the system into the implantation catheter. Physician did not notice a gap between pusher and coil prior to release. If issue recurred it could lead to embolization of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032582-2016-00013 |
| MDR Report Key | 8313090 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2016-06-21 |
| Date Mfgr Received | 2016-06-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 1014640.01 |
| 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 |