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 2020-03-20 for PENUMBRA ENGINE CANISTER PAPS3-A PAPS3 manufactured by Penumbra, Inc..
[185232063]
Device code: 3191 - appropriate code not available to describe the canister issue 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
[185232064]
The patient was undergoing a thrombectomy in the left anterior descending artery (lad) using a penumbra engine canister (canister), penumbra engine (engine), and indigo system catrx aspiration catheter (catrx). During the procedure, the physician placed the catrx in the target vessel and the canister in the receptacle of the engine. While the engine was powered on, only three out of the four indicator lights were illuminated on the engine; therefore, the canister was removed. The procedure was completed using another canister and the same engine and catrx. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00425 |
| MDR Report Key | 9863081 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-26 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-20 |
| 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 ENGINE CANISTER |
| Generic Name | DXE |
| Product Code | DXE |
| Date Received | 2020-03-20 |
| Model Number | PAPS3-A |
| Catalog Number | PAPS3 |
| Lot Number | S11577 |
| 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 | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |