MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-11 for PENUMBRA SYSTEM JETD REPERFUSION CATHETER 5MAXJETDKIT manufactured by Penumbra, Inc..
[184328805]
Additional 510(k)# that also applies to this complaint: (b)(4). The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This report is associated with mfr report number: 3005168196-2020-00315.
Patient Sequence No: 1, Text Type: N, H10
[184328806]
The patient was undergoing a thrombectomy procedure to treat a supraclinoid carotid occlusion using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system jetd reperfusion catheter (jetd), and a neuron max 6f 088 long sheath (neuron max). It was noted that the patient anatomy was tortuous. During the procedure, the physician advanced the neuron max into the patient, then used the 3maxc to bring up the jetd to the treatment site through the neuron max. While attempting to remove the 3maxc, the physician experienced resistance. The physician then pulled harder and noticed that the 3maxc was stuck in the jetd. The physician then pulled even harder and was able to remove the 3maxc. However, upon removal, it was noticed that the 3maxc was broken and only the proximal end of the 3maxc was removed. The physician then removed the jetd and noticed that the broken distal end of the 3maxc was inside the jetd. The procedure was completed using a microcatheter, a stent retriever and the same neuron max. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00316 |
| MDR Report Key | 9818474 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-29 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-11 |
| 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 JETD REPERFUSION CATHETER |
| Generic Name | NRY |
| Product Code | NRY |
| Date Received | 2020-03-11 |
| Model Number | 5MAXJETDKIT |
| Catalog Number | 5MAXJETDKIT |
| Lot Number | C17810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |