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 2020-03-18 for INDIGO SYSTEM CAT RX ASPIRATION CATHETER CATRXKIT manufactured by Penumbra, Inc..
[188412672]
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
[188412673]
The patient was undergoing a thrombectomy procedure in the circumflex artery using an indigo system catrx aspiration catheter (catrx) and non-penumbra sheath. During the procedure, it was reported that the physician attempted to use a non-penumbra aspiration device and then ballooned a segment burden with heavy thrombus. However, thrombus traveled downstream to the circumflex artery and occluded the circumflex. The physician advanced catrx down the circumflex and completed two passes. After the second pass, the catrx was removed and the physician took a picture and discovered that the circumflex was still occluded. While attempting to advance the same catrx to make another pass, the physician noticed that the catrx to be kinked approximately three to four inches from the distal tip. Therefore, the catrx was removed the procedure was completed using a new catrx 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 | 3005168196-2020-00382 |
| MDR Report Key | 9849835 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-23 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-18 |
| 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 RX ASPIRATION CATHETER |
| Generic Name | DXE |
| Product Code | DXE |
| Date Received | 2020-03-18 |
| Model Number | CATRXKIT |
| Catalog Number | CATRXKIT |
| Lot Number | F94432 |
| 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 | 2020-03-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |