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..
[18514904]
During attempts to probe the neural foramen with the baxano ipsilateral bare probe at the l1-2 disc level, the catheter portion of the probe detached just distal to the tip. The tip and approximately 2-3 mm of catheter remained intramuscularly (left psoas muscle) just lateral to the l1-2 disc level. The physician elected not to retrieve the tip from the patient, and the patient was discharged without further clinical sequelae. On 02/06/2009, the company spoke to the physician. No additional clinical sequelae was reported as a result of the tip dislodgement.
Patient Sequence No: 1, Text Type: D, B5
[18698053]
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 | 3006324586-2009-00001 |
| MDR Report Key | 1334594 |
| Report Source | 07 |
| Date Received | 2009-03-04 |
| Date of Report | 2009-03-02 |
| Date of Event | 2009-02-02 |
| 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 | 0 |
| 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 |
| Returned To Mfg | 2009-02-06 |
| Catalog Number | FG0356-05 |
| Lot Number | 081219901 |
| 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 |