MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-01 for INDIGO SYSTEM SEPARATOR 8 SEP8-A SEP8 manufactured by Penumbra, Inc..
[185227639]
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
[185227640]
The patient was undergoing a thrombectomy procedure in the femoral popliteal artery using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), a non-penumbra 9f sheath introducer, and guidewire. During the procedure, the physician advanced the cat8 over the guidewire through the 9f sheath to the target site. The guidewire was then removed and the sep8 was advanced through the cat8. Next, aspiration was initiated. While advancing the sep8 in and out of the cat8, the physician noticed under fluoroscopy that the wire distal to the bulb of the sep8 was broken. Therefore, the broken sep8 was aspirated out using the cat8. The procedure was completed using the cat8. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00122 |
| MDR Report Key | 9656361 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-01 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-06 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-02-01 |
| 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 8 |
| Generic Name | QEW |
| Product Code | QEW |
| Date Received | 2020-02-01 |
| Model Number | SEP8-A |
| Catalog Number | SEP8 |
| Lot Number | F91780 |
| 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 | 2020-02-01 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-01 |