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 2020-03-05 for INDIGO SYSTEM ASPIRATION CATHETER 6 CAT6KIT-A CAT6KIT manufactured by Penumbra, Inc..
[182205680]
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
[182205681]
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6), a non-penumbra sheath and guidewire. During the procedure, while attempting to advance the cat6 with the peel away sheath, over the guidewire and into the sheath, the cat6 would not advance; therefore, the physician decided to remove it. While removing the cat6, the physician experienced resistance and upon removal, it was noticed that the cat6 was ovalized approximately 10 cm from the distal end. The procedure was completed using a new cat6, another sheath and the same guidewire. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00303 |
| MDR Report Key | 9794414 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-14 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-05 |
| 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 ASPIRATION CATHETER 6 |
| Generic Name | DXE |
| Product Code | DXE |
| Date Received | 2020-03-05 |
| Model Number | CAT6KIT-A |
| Catalog Number | CAT6KIT |
| Lot Number | F93474 |
| 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 | 2020-03-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |