MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for PENUMBRA COIL 400 4002C1040 manufactured by Penumbra, Inc..
[188357639]
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10
[188357640]
The patient was undergoing a coil embolization procedure to treat a mid-basilar artery aneurysm using penumbra coil 400s (pc400s), a px slim delivery microcatheter (px slim) and a neuron max 6f 088 long sheath (neuron max). During the procedure, the physician successfully implanted two pc400s in the aneurysm using the px slim and neuron max. The physician then attempted to place the third pc400 into the aneurysm but was unsuccessful; therefore, the physician reduced the slack of the px slim and attempted again to place the pc400 but was also unsuccessful; therefore, the pc400 was removed. Upon removal of the pc400, it was noticed that there was a lot of clot on the pc400; therefore, the pc400 was rinsed. The physician then attempted to advance the pc400 through the px slim but the px slim got kicked out of placed. The px slim was then secured back into placed and the physician attempted again to place the pc400 into the aneurysm but was unsuccessful. Therefore, the pc400 was removed. The procedure was completed using a new pc400 and the same px slim. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00467 |
| MDR Report Key | 9907866 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Model Number | 4002C1040 |
| Catalog Number | 4002C1040 |
| Lot Number | F85248 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2020-03-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |