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 2020-03-20 for PENUMBRA SMART COIL 400SMTHXSFT0306 manufactured by Penumbra, Inc..
[185235407]
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
[185235408]
The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) using penumbra smart coils and a penumbra smart coil detachment handle (handle). During the procedure, the physician successfully implanted nine smart coils using the handle. After two failed attempts to detach the tenth smart coil using the handle, the physician tried to manually break the detachment zone. However, the proximal end of the wire broke off instead. The physician tried to break the detachment zone again, but the proximal end of the pull wire continued to break off during each attempt until the physician reached the rotating hemostasis valve (rhv). Therefore, the smart coil was removed. The procedure was completed using five additional smart coils and the same handle. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00420 |
| MDR Report Key | 9862643 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 400SMTHXSFT0306 |
| Catalog Number | 400SMTHXSFT0306 |
| Lot Number | F81196 |
| 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 | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |