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 ASPIRATION CATHETER 8 CAT8XTORQ115KIT-A CAT8XTORQ115KIT manufactured by Penumbra, Inc..
[188406685]
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
[188406686]
The patient was undergoing a thrombectomy procedure to treat a deep vein thrombosis (dvt) using an indigo system aspiration catheter 8 (cat8), non-penumbra sheath and, non-penumbra glide catheter. During the procedure, it was reported that the physician was able to remove a large volume of the clot using a standard coring technique following a tissue plasminogen activator (tpa) infusion with the glide catheter. Next, while advancing the cat8, the physician noticed that tip of the cat8 started to slightly bend and the flow into the canister became slow. The physician continued to use the same cat8 to complete four passes and completed the procedure. After the procedure, upon further inspection of the cat8 distal tip, the physician noticed that the distal deflection to be slightly kinked. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00386 |
| MDR Report Key | 9850223 |
| 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 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDIGO SYSTEM ASPIRATION CATHETER 8 |
| Generic Name | DXE |
| Product Code | DXE |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-02 |
| Model Number | CAT8XTORQ115KIT-A |
| Catalog Number | CAT8XTORQ115KIT |
| Lot Number | F91267 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | 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 Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |