MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-04 for BAXANO IPSILATERAL BARE PROBE FG0356-05 manufactured by Baxano, Inc..
[1075977]
Following successful access to the neural foramen at the l4-5 disc level, the physician pulled up on the device. Manipulation of the probe caused the device to fracture at the catheter portion of the guide just distal to the hypotube. The device remained intact as it was withdrawn, and no clinical sequelae occurred as a result of the fracture. On (b) (6) 2009, the company spoke to the physician. No additional clinical sequelae was reported as a result of the device malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8174766]
The device was inspected. Manufacturing and material records were evaluated and components and processes were within specification. A corrective action was initiated to evaluate design contributions to the malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006324586-2009-00002 |
| MDR Report Key | 1334593 |
| Report Source | 07 |
| Date Received | 2009-03-04 |
| Date of Report | 2009-03-02 |
| Date of Event | 2009-02-06 |
| Date Mfgr Received | 2009-02-06 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2010-01-27 |
| 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 | 0 |
| Manufacturer Contact | PATTY HEVEY |
| Manufacturer Street | 2660 MARINE WAY, SUITE B |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal | 94043 |
| Manufacturer Phone | 6509371400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAXANO IPSILATERAL BARE PROBE |
| Generic Name | PROBE |
| Product Code | GZI |
| Date Received | 2009-03-04 |
| Catalog Number | FG0356-05 |
| Device Expiration Date | 2009-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXANO, INC. |
| Manufacturer Address | 2660 MARINE WAY, SUITE B MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-04 |