MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for RUBY COIL RBY4C1240-A RBY4C1240 manufactured by Penumbra, Inc..
[187955785]
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10
[187955786]
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern). It was noted that the patient anatomy was tortuous. During the procedure, the physician successfully implanted six ruby coils in the target vessel using the lantern. While advancing the seventh ruby coil through the lantern, the physician experienced resistance and decided to retract the ruby coil. While retracting the ruby coil, it unintentionally detached inside the lantern. Therefore, the physician removed the lantern containing the detached ruby coil and then removed the ruby coil. The procedure was completed using three additional ruby coils and the same lantern. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00455 |
| MDR Report Key | 9891595 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-05 |
| 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 | RUBY COIL |
| Generic Name | HCG, KRD |
| Product Code | HCG |
| Date Received | 2020-03-27 |
| Model Number | RBY4C1240-A |
| Catalog Number | RBY4C1240 |
| Lot Number | F85719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |