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 2020-03-03 for PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7KIT-B 5MAXJET7KIT manufactured by Penumbra, Inc..
[188503153]
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
[188503154]
The patient was undergoing a thrombectomy procedure in the internal carotid artery terminus (ica-t) and the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra sheath, non-penumbra stent retriever and, non-penumbra microcatheter. During the procedure, while treating for an ica stenosis, the physician performed a balloon angioplasty and stenting of the ica. It was reported that the clot moved from the proximal ica to the ica-t and m1. Next, the physician tracked the jet7 up with the microcatheter and guidewire and then deployed the stent retriever. However, while attempting to retract the stent retriever back into the jet7, slight resistance was encountered. Therefore, the physician removed the stent retriever and jet7 noticed that the jet7 was kinked and slightly stretched proximally to the distal tip. The procedure was completed using a new jet7 and the same sheath. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00283 |
| MDR Report Key | 9783185 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-03 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 5MAXJET7KIT-B |
| Catalog Number | 5MAXJET7KIT |
| Lot Number | F94085 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-03 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |