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 2020-03-25 for POD PACKING COIL RBYPODJ60-A RBYPODJ60 manufactured by Penumbra, Inc..
[185231106]
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report number: 3005168196-2020-00434.
Patient Sequence No: 1, Text Type: N, H10
[185231107]
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (pod pcs), additional coils, and a non-penumbra microcatheter. It was noted that the patient's anatomy was tortuous and calcified. During the procedure, the physician encountered resistance while advancing a pod pc past its initial position within its introducer sheath. Therefore, the pod pc was removed. Upon advancement of the next pod pc, it was reported that the coil was not moving in tandem with the pusher assembly. While making another attempt to advance and retract the pod pc, the physician realized that the pod pc had unintentionally detached within the microcatheter. Therefore, the microcatheter was withdrawn and the pod pc was removed. The procedure was completed using a non-penumbra coil 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 | 3005168196-2020-00433 |
| MDR Report Key | 9881282 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-28 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | RBYPODJ60-A |
| Catalog Number | RBYPODJ60 |
| Lot Number | F92793 |
| 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 | 2020-03-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |