MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for PENUMBRA COIL 400 4004C0408-A 4004C0408 manufactured by Penumbra, Inc..
[185228434]
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report number: 1. 3005168196-2020-00446.
Patient Sequence No: 1, Text Type: N, H10
[185228435]
The patient was undergoing a coil embolization procedure to treat a carotid cavernous fistula (ccf) in the internal carotid artery (ica) using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim). During the procedure, the physician successfully placed a pc400 into the target vessel using the px slim. Upon removal of the pusher assembly, it was noticed that the pusher assembly broke into two pieces, leaving a broken piece stuck within the px slim. Therefore, the px slim containing the broken piece of the pusher assembly was removed. The procedure was completed using additional pc400s and a new px slim. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00445 |
| MDR Report Key | 9886560 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-03 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-26 |
| 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 | MS. VERONICA FARRIS |
| Manufacturer Street | ONE PENUMBRA PLACE |
| Manufacturer City | ALAMEDA CA 94502 |
| Manufacturer Country | US |
| Manufacturer Postal | 94502 |
| Manufacturer Phone | 5107483200 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENUMBRA COIL 400 |
| Generic Name | HCG, KRD |
| Product Code | HCG |
| Date Received | 2020-03-26 |
| Model Number | 4004C0408-A |
| Catalog Number | 4004C0408 |
| Lot Number | F90201 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENUMBRA, INC. |
| Manufacturer Address | ONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502 |
| Product Code | --- |
| Date Received | 2020-03-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |