MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for NIT-OCCLUD PDA 145116 manufactured by Pfm Medical Mepro Gmbh.
[136873608]
The sample was provided and was used to conduct an investigation. The device history record (dhr) has been reviewed and showed no deviations. The coil, item 145116, was still mounted on the carrier and with the proximal part still in the transportation sheath. The catheter was contaminated with blood and no longer usable. If the catheter has not been flushed enough during implantation, a graft may form which then makes the reason for the complaint plausible. To reconstruct the reason for the complaint, a new implantation catheter was used. The coil could be easily pushed through the catheter, configured, and withdrawn without problems. No further similar complaints were reported to mepro in the past. Based on previous experience, insufficient rinsing cannot be ruled out. The complaint is not justified.
Patient Sequence No: 1, Text Type: N, H10
[136873609]
The coil went out of the transportation sheath. Doctor's report: "after introducing the coil, we tried to reposition it. At the first trial of reposition the loops stucked on the catheter and refused to go back inside the catheter or refigured again at all. After flushing the system several times, we tried to pull it harder to let it move, then it's went out of the transportation sheath. " could result in embolism of the device is occurred again required intervention to remove the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005704822-2018-00001 |
| MDR Report Key | 8316341 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-01-01 |
| Date Added to Maude | 2019-02-07 |
| 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 MEPRO GMBH |
| Manufacturer Street | AM S |
| Manufacturer City | NONNWEILER-OTZENHAUSEN, SAARLAND 66620 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 66620 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NIT-OCCLUD PDA |
| Generic Name | PDA OCCLUDER |
| Product Code | MAE |
| Date Received | 2019-02-07 |
| Returned To Mfg | 2018-01-15 |
| Model Number | 145116 |
| Catalog Number | 145116 |
| Lot Number | 1021317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFM MEDICAL MEPRO GMBH |
| Manufacturer Address | AM S?TERBERG 4 NONNWEILER-OTZENHAUSEN, SAARLAND 66620 GM 66620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-07 |