MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-27 for ASPIRATION TUBING SCW manufactured by Penumbra, Inc..
[187956997]
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
[187956998]
The patient was undergoing a thrombectomy procedure in the basilar artery using an aspiration tubing (tubing), penumbra system 4max reperfusion catheter (4maxc), and penumbra system aspiration pump max 110 (pump max). During the procedure, the physician connected the 4maxc to the pump max using the tubing. However, the vacuum pressure from the pump max was not reaching the desired -28 inhg despite confirming there were no loose connections; therefore, the tubing was removed. The procedure was completed using another tubing and the same 4maxc and pump max. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00459 |
| MDR Report Key | 9892265 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-29 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-27 |
| 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 | ASPIRATION TUBING |
| Generic Name | NRY |
| Product Code | NRY |
| Date Received | 2020-03-27 |
| Catalog Number | SCW |
| Lot Number | F74809 |
| Device Expiration Date | 2020-03-06 |
| 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 | 2020-03-27 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |