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 2020-03-30 for POD PACKING COIL RBYPODJ15-A RBYPODJ15 manufactured by Penumbra, Inc..
[188385337]
The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report numbers: 1. 3005168196-2020-00430.
Patient Sequence No: 1, Text Type: N, H10
[188385338]
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, pod packing coils (pod pcs), a ruby coil detachment handle (handle), and a non-penumbra microcatheter. During the procedure, the physician placed a ruby coil into the target vessel using the handle. While advancing the next coil, a pod pc, through the microcatheter, the physician experienced resistance; subsequently, the pod pc was retracted. While attempting to re-advance the same pod pc, the physician experienced resistance at the same location; therefore, the pod pc was removed. The physician continued the procedure by advancing a new pod pc into the target vessel and attempted to detach it using the handle; however, the red handle slider did not retract; therefore, the handle was not used. The procedure was completed using a new handle to detach the same pod pc. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00429 |
| MDR Report Key | 9901392 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| 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 | 2020-03-30 |
| 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 | POD PACKING COIL |
| Generic Name | HCG, KRD |
| Product Code | HCG |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-12 |
| Model Number | RBYPODJ15-A |
| Catalog Number | RBYPODJ15 |
| Lot Number | F93494 |
| 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 | 2020-03-30 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |