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 2020-01-07 for INDIGO SYSTEM SEPARATOR 6 SEP6 manufactured by Penumbra, Inc..
[176997040]
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.
Patient Sequence No: 1, Text Type: N, H10
[176997041]
The patient was undergoing a thrombectomy procedure in the right superficial femoral artery (sfa) using an indigo system separator 6 (sep6). During the procedure, while removing the sep6 through the rotating hemostasis valve (rhv) to exchange it for a wire, the sep6 became unraveled off the pusher; therefore, the physician removed the entire sep6. It was reported that the rhv had not been loosened prior to removing the sep6. The procedure was completed using another sep6. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00037 |
| MDR Report Key | 9560386 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-19 |
| Device Manufacturer Date | 2019-05-28 |
| Date Added to Maude | 2020-01-07 |
| 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 | QEW |
| Product Code | QEW |
| Date Received | 2020-01-07 |
| Catalog Number | SEP6 |
| Lot Number | F90577 |
| 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 | 2020-01-07 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |