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 2020-01-24 for INDIGO SYSTEM CAT RX ASPIRATION CATHETER CATRXKIT manufactured by Penumbra, Inc..
[176432716]
The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10
[176432717]
The patient was undergoing a thrombectomy procedure in the left anterior descending artery (lad) using an indigo system catrx aspiration catheter (catrx), penumbra engine (engine) and, non-penumbra guide catheter. During the procedure, the physician was unable to advance the catrx with the aspiration turned on; therefore, the engine was turned off. The physician then advanced the catrx into the target vessel and turned the engine back on to aspirate from distal to the proximal end of the lad. The procedure was completed using the same catrx, engine and, guide catheter. It was reported that the physician noticed a dissection in the lower lad during the procedure when taking a few pictures. The dissection was treated using a stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00098 |
| MDR Report Key | 9625568 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-03 |
| Date of Event | 2020-01-02 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2019-09-05 |
| Date Added to Maude | 2020-01-24 |
| 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 | QEX |
| Product Code | QEX |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2020-01-09 |
| Model Number | CATRXKIT |
| Catalog Number | CATRXKIT |
| Lot Number | F92891 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-01-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-01-24 |