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 2020-02-05 for INDIGO SYSTEM CATRX ASPIRATION CATHETER CATRXKIT manufactured by Penumbra, Inc..
[185227105]
The product lot number was not provided, therefore, the manufacturing records could not be reviewed. The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[185227106]
The patient was undergoing a thrombectomy procedure in the right coronary artery (rca) using an indigo system catrx aspiration catheter (catrx) and non-penumbra guide catheter. During the procedure, it was reported that due to a tight fit, the physician was experiencing resistance using the guidewire along side the catrx and, therefore, the physician decided to remove catrx. However, while retracting, the catrx broke into two segments towards the wire exit port within the guide catheter. Therefore, the guide catheter was removed containing the broken catrx. The physician ended the procedure at this point. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00133 |
| MDR Report Key | 9674242 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-05 |
| 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 CATRX ASPIRATION CATHETER |
| Generic Name | QEX |
| Product Code | QEX |
| Date Received | 2020-02-05 |
| Catalog Number | CATRXKIT |
| 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 | 2020-02-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |