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 2020-01-02 for INDIGO SYSTEM SEPARATOR D SEPD manufactured by Penumbra, Inc..
[174402865]
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
[174402866]
The patient was undergoing a thrombectomy procedure in the left femoral vein using an indigo system separator d (sepd) and indigo system catd aspiration catheter (catd). During the procedure, the physician completed approximately ten to fifteen passes in the target vessel using the sepd and catd. It was reported that the physician had difficulty crossing certain parts due to the clot being extremely chronic. While advancing the sepd in and out of the catd on the next pass, the physician noticed that the distal bulb wire of the sepd had broken off under fluoroscopy. Subsequently, the physician attempted to aspirate and retrieve the broken distal bulb wire but was unsuccessful as the clot was too chronic. The physician then ballooned the vessel and decided to leave it alone. The procedure ended at this point. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2019-02459 |
| MDR Report Key | 9537601 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-12-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2019-04-30 |
| Date Added to Maude | 2020-01-02 |
| 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 D |
| Generic Name | QEW |
| Product Code | QEW |
| Date Received | 2020-01-02 |
| Catalog Number | SEPD |
| Lot Number | F89948 |
| 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 | 2020-01-02 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |