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 2020-03-26 for INDIGO SYSTEM ASPIRATION CATHETER 6 CAT6KIT-A CAT6KIT manufactured by Penumbra, Inc..
[185228761]
The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Patient Sequence No: 1, Text Type: N, H10
[185228762]
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) and the popliteal and peroneal arteries using an indigo system aspiration catheter 6 (cat6) from an indigo system aspiration catheter 6 kit, a non-penumbra support catheter, and a non-penumbra sheath. During the procedure, the support catheter was within the cat6 and a peel-away introducer sheath was used to introduce the devices into the valve of the sheath. However, the physician encountered resistance and subsequently, the cat6 became ovalized. Therefore, the cat6 was removed. The procedure was completed using a new cat6, the same sheath, and the same support catheter. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00440 |
| MDR Report Key | 9884209 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-26 |
| 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 ASPIRATION CATHETER 6 |
| Generic Name | DXE |
| Product Code | DXE |
| Date Received | 2020-03-26 |
| Model Number | CAT6KIT-A |
| Catalog Number | CAT6KIT |
| Lot Number | F92921 |
| 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 | 2020-03-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |