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 2020-02-28 for PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7KIT-B 5MAXJET7KIT manufactured by Penumbra, Inc..
[181787973]
The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10
[181788074]
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7) and neuron max 6f 088 long sheath (neuron max). During the procedure, the physician completed three passes in the target vessel using the jet7 and neuron max. A contrast run was then performed, which led the jet7 to break about an inch from the distal tip. It was reported that contrast went through the side of the jet7 and the side wall of the vessel ruptured; therefore, the jet7 was removed. The procedure stopped at this point. The patient was considered stable post-procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00275 |
| MDR Report Key | 9772301 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-08 |
| Date of Event | 2020-02-08 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-02-28 |
| 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 | 2020-02-28 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 5MAXJET7KIT-B |
| Catalog Number | 5MAXJET7KIT |
| Lot Number | F93960 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-28 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |