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 2020-03-17 for PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7KIT-B 5MAXJET7KIT manufactured by Penumbra, Inc..
[183915488]
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation. Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5093205.
Patient Sequence No: 1, Text Type: N, H10
[183915489]
The patient was undergoing a thrombectomy procedure in the middle cerebral artery using a penumbra system jet 7 reperfusion catheter (jet7) and neuron max 6f 088 long sheath (neuron max). During the procedure, the physician made an unknown number of passes in the target vessel using the jet7 and neuron max. While removing the jet7 out of the neuron max, the jet7 became damaged and began to unravel inside the neuron max. The jet7 was carefully removed from the neuron max. It is unknown how the procedure was completed. There was no report of an adverse effect to the patient. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00372 |
| MDR Report Key | 9845743 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-17 |
| 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 SYSTEM JET7 REPERFUSION CATHETER |
| Generic Name | NRY |
| Product Code | NRY |
| Date Received | 2020-03-17 |
| Model Number | 5MAXJET7KIT-B |
| Catalog Number | 5MAXJET7KIT |
| Lot Number | F94084 |
| 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 | 2020-03-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |