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 SYSTEM 3MAX REPERFUSION CATHETER 3MAXC-B 3MAXC manufactured by Penumbra, Inc..
[185250975]
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
[185250976]
The patient was undergoing a thrombectomy procedure in the right m2 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), penumbra system ace 64 reperfusion catheter (ace64), non-penumbra balloon guide catheter and, non-penumbra stent retriever. It was noted that the patient anatomy was tortuous. During the procedure, the physician completed one pass using the 3maxc, ace64, balloon guide catheter and, stent retriever. However, while retracting the stent retriever back into the 3maxc, the physician noticed that the 3maxc stretched and broke approximately an inch and a half from the distal tip. It was reported that the broken 3maxc was captured while retracting the stent retriever. Therefore, the physician removed the 3maxc and stent retriever as one unit. The procedure ended at this point, and a thrombolysis in cerebral infarction (tici) grade 2 was achieved. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00408 |
| MDR Report Key | 9861265 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-27 |
| 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 SYSTEM 3MAX REPERFUSION CATHETER |
| Generic Name | NRY |
| Product Code | NRY |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-13 |
| Model Number | 3MAXC-B |
| Catalog Number | 3MAXC |
| Lot Number | F93330 |
| 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 | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |