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 2020-03-18 for INDIGO SYSTEM SEPARATOR 6 SEP6 manufactured by Penumbra, Inc..
[188405716]
The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Patient Sequence No: 1, Text Type: N, H10
[188405717]
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system separator 6 (sep6), indigo system aspiration catheter 6 (cat6), and non-penumbra sheath. It was reported that the patient had a heavy thrombus burden. During the procedure, the physician completed three to four passes in the target vessel using the sep6 , cat6, and sheath. Upon removal, the sep6 started to unravel two inches back from the bulb. The entire sep6 was then removed. It was noted that the physician experienced resistance on all passes due to the thrombus burden. The procedure was completed using another sep6 and the same cat6 and sheath. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00383 |
| MDR Report Key | 9849954 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-21 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-18 |
| 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 | INDIGO SYSTEM SEPARATOR 6 |
| Generic Name | DXE |
| Product Code | DXE |
| Date Received | 2020-03-18 |
| Model Number | SEP6 |
| Catalog Number | SEP6 |
| 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 | 2020-03-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |