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 2020-01-22 for INDIGO SYSTEM CATRX ASPIRATION CATHETER CATRXKIT manufactured by Penumbra, Inc..
[177019196]
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
[177019197]
The patient was undergoing a thrombectomy procedure in the right coronary artery (rca) using indigo system catrx aspiration catheters (catrxs) and a non-penumbra guide catheter. During the procedure, the physician found a catrx was kinked prior to removal from the packaging. The damage to the catrx was found prior to use, and therefore, it was not used in the procedure. The physician then opened another catrx. While advancing the catrx through the guide catheter in the target vessel, the proximal end of the catrx kinked and broke; therefore, it was removed. The procedure was completed using the third catrx and the same guide catheter. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00016 |
| MDR Report Key | 9616912 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-22 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-01-22 |
| 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 | 2020-01-22 |
| Returned To Mfg | 2020-01-02 |
| Model Number | CATRXKIT |
| Catalog Number | CATRXKIT |
| Lot Number | F91789 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-01-22 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |