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 CAT 3 ASPIRATION CATHETER CAT3-A CAT3 manufactured by Penumbra, Inc..
[187955535]
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
[187955536]
The patient was undergoing a thrombectomy procedure in the posterior tibial artery using an indigo system cat3 aspiration catheter (cat3) and a non-penumbra sheath. During the procedure, the physician advanced the cat3 through the sheath, then initiated the aspiration; however, no aspiration was observed and the cat3 was therefore removed. Upon removal, it was noticed that the cat3 was kinked at the midshaft. The physician then flushed the cat3 and it separated in two pieces exposing the inner coiling. The procedure was completed using a new cat3 and the same sheath. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00456 |
| MDR Report Key | 9892120 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-05 |
| 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 CAT 3 ASPIRATION CATHETER |
| Generic Name | DXE |
| Product Code | DXE |
| Date Received | 2020-03-27 |
| Model Number | CAT3-A |
| Catalog Number | CAT3 |
| Lot Number | F88079 |
| 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 |