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 CATRX ASPIRATION CATHETER CATRXKIT manufactured by Penumbra, Inc..
[188405259]
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
[188405260]
The patient was undergoing a thrombectomy in the right anterior tibial (at) artery using an indigo system catrx aspiration catheter (catrx) and non-penumbra sheath. During the procedure, while advancing the catrx through the sheath, the physician experienced resistance; therefore, it was removed. It was noted that there was difficulty pulling the catrx out of the sheath. Upon removal, the catrx was observed to be kinked at the shaft and ovalized 29 cm beyond the rapid exchange port. The procedure was completed using another 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 | 3005168196-2020-00394 |
| MDR Report Key | 9851047 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-24 |
| 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 |
| Device Manufacturer Date | 2019-12-17 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDIGO SYSTEM CATRX ASPIRATION CATHETER |
| Generic Name | DXE |
| Product Code | DXE |
| Date Received | 2020-03-18 |
| Model Number | CATRXKIT |
| Catalog Number | CATRXKIT |
| Lot Number | F94982 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | 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 | 2020-03-18 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |