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 PENUMBRA SMART COIL 400SMTSFT4H10 manufactured by Penumbra, Inc..
[187955076]
The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The product lot number was not provided, therefore, the manufacturing records could not be reviewed. This report is associated with mfr report number: 1. 3005168196-2020-00458.
Patient Sequence No: 1, Text Type: N, H10
[187955077]
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and a non-penumbra microcatheter. It was reported that the patient anatomy was tortuous. During the procedure, while attempting to advance the smart coil into the aneurysm, the physician had difficulty and the smart coil kicked the microcatheter out of the aneurysm. Subsequently, the physician was able to successfully place the smart coil in the aneurysm. The physician then had difficulty while attempting to advance the next smart coil into the aneurysm; therefore, the physician re-sheathed the smart coil then removed the microcatheter. Next, the physician placed another microcatheter and attempted to advance the same smart coil into the aneurysm; however, the smart coil kicked the microcatheter out of the aneurysm. It was also reported that the smart coil did not take its intended shape; therefore, it was removed. The procedure was completed using two other coils and the same microcatheter. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00457 |
| MDR Report Key | 9892178 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-06 |
| 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 | 2020-03-06 |
| 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 | PENUMBRA SMART COIL |
| Generic Name | HCG, KRD |
| Product Code | HCG |
| Date Received | 2020-03-27 |
| Model Number | 400SMTSFT4H10 |
| Catalog Number | 400SMTSFT4H10 |
| 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 |