MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for INDIGO SYSTEM SEPARATOR 6 SEP6 manufactured by Penumbra, Inc..
[188351877]
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10
[188351878]
The patient was undergoing a thrombectomy procedure in the anterior artery using an indigo system separator 6 (sep6) and an indigo system aspiration catheter 6 (cat6). It was reported that there was a stenosis at the target location. During the procedure, the physician engaged the cat6 through the stenosis with force, then experienced resistance while advancing the sep6 through the cat6. While advancing the sep6 in and out of the cat6, the physician noticed under fluoroscopy that the wire distal to the bulb of the sep6 was missing; therefore, the sep6 was removed. It was reported that the broken wire of the sep6 was found on the sterilized table, and it is unknown how it ended up on the sterilized table. It was also reported the cat6 kinked while advancing through the stenosis. The procedure was completed using a new sep6 and same cat6. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00463 |
| MDR Report Key | 9892273 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-02-24 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | SEP6 |
| Catalog Number | SEP6 |
| Lot Number | F87358 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-27 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |