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 2020-01-28 for INDIGO SYSTEM SEPARATOR 6 SEP6 manufactured by Penumbra, Inc..
[176987100]
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
[176987101]
The patient was undergoing a thrombectomy procedure in the popliteal artery using an indigo system separator 6 (sep6), indigo system aspiration catheter 6 (cat6) and non-penumbra sheath. During the procedure, after approximately five minutes of using the sep6 and cat6 in the target vessel, the hospital technician had difficulty advancing the sep6 out of the distal tip of the cat6. Therefore, the sep6 was removed and the thrombus was discovered to be wrapped around the sep6 distal bulb. The thrombus was removed and the sep6 was advanced back into the cat6 to make another pass. After approximately two to three minutes of using the sep6, the hospital technician noticed the sep6 would not come out of the distal tip of the cat6. The sep6 wire was then advanced further and the hospital technician noticed a loop at the distal end of the sep6 wire. Therefore, the sep6 was removed and it was discovered that sep6 distal bulb was no longer attached. It was reported that the missing sep6 bulb was not found inside the patient under fluoroscopy and was not visually found inside of the pump canister. The procedure was then completed by administering tissue plasminogen activator (tpa) drip to try and dissolve the remaining thrombus. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00118 |
| MDR Report Key | 9638747 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-08 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-01-28 |
| 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 SEPARATOR 6 |
| Generic Name | QEW |
| Product Code | QEW |
| Date Received | 2020-01-28 |
| Returned To Mfg | 2020-01-13 |
| Model Number | SEP6 |
| Catalog Number | SEP6 |
| Lot Number | F92201 |
| 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 | 2020-01-28 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |