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 2020-03-26 for NEURON SELECT CATHETER 5F BMK6F95MBER120 manufactured by Penumbra, Inc..
[185229292]
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 number: 3005168196-2020-00448.
Patient Sequence No: 1, Text Type: N, H10
[185229293]
The patient was undergoing a thrombectomy procedure in the right radial artery using a benchmark 6f 071 delivery catheter (benchmark) and a neuron select catheter 5f (5f select) from a benchmark kit. During the procedure, the physician encountered resistance while advancing the 5f select into the benchmark. Upon removal of the 5f select, the physician found a wire from the benchmark attached. Subsequently, the physician realized the benchmark was unraveling. It was also reported that purple coating was coming off of the 5f select. Therefore, the benchmark and 5f select were no longer used in the procedure. The procedure was completed using a new benchmark and a new 5f select from a new benchmark kit. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00449 |
| MDR Report Key | 9886627 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-29 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-26 |
| 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 | NEURON SELECT CATHETER 5F |
| Generic Name | DQY |
| Product Code | DQY |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-06 |
| Model Number | BMK6F95MBER120 |
| Catalog Number | BMK6F95MBER120 |
| Lot Number | F93649 |
| 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 | 2020-03-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |