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 2020-01-29 for INDIGO SYSTEM ASPIRATION CATHETER 6 CAT6KIT-A CAT6KIT manufactured by Penumbra, Inc..
[176989262]
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
[176989263]
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) and popliteal artery using an indigo system aspiration catheter 6 (cat6) and non-penumbra sheath. It was reported that the patient? S anatomy was tortuous. During the procedure, the physician successfully aspirated the clot from the upper sfa using the cat6 without a peal away sheath and the sheath. Next, while advancing the cat6 through the sheath in a more tortuous section of the target vessel, the physician felt the cat6 kinked; therefore, it was removed. Upon removal, the physician observed the kink. The procedure was completed using an indigo system catrx aspiration catheter (catrx) and another non-penumbra sheath. It was noted that not all of the clot in the distal popliteal artery was removed due to the catrx being too small. Subsequently, the physician administered dripping for the patient and will perform another procedure using another cat6 the next day. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00111 |
| MDR Report Key | 9644449 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-07 |
| Date of Event | 2020-01-07 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-27 |
| Date Added to Maude | 2020-01-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 ASPIRATION CATHETER 6 |
| Generic Name | QEW |
| Product Code | QEW |
| Date Received | 2020-01-29 |
| Returned To Mfg | 2020-01-14 |
| Model Number | CAT6KIT-A |
| Catalog Number | CAT6KIT |
| Lot Number | F90553 |
| 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 | 2020-01-29 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |