MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-05 for KYPHON FAD CATHETER D01A manufactured by Kyphon, Inc..
[732201]
During functional anesthetic discogram in hosp pain clinic, it was noted that a small portion of a guide wire fractured and was retained in disk l4-l5. The physician did not remove the wire; he notified the mfr who states they have forwarded this information to the fda. Lot number unclear. Please see following lot numbers for potential match. These were derived from shipments surrounding affected procedure. J7053011, j7090623, j7080606, j7073012, j7060603.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004326 |
| MDR Report Key | 939364 |
| Date Received | 2007-11-05 |
| Date of Report | 2007-11-05 |
| Date of Event | 2007-10-19 |
| Date Added to Maude | 2007-11-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON |
| Generic Name | FAD CATHETER SYSTEM |
| Product Code | OCJ |
| Date Received | 2007-11-05 |
| Model Number | FAD CATHETER |
| Catalog Number | D01A |
| Lot Number | J7090623 |
| ID Number | SEE SECTION B |
| Device Expiration Date | 2008-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 915003 |
| Manufacturer | KYPHON, INC. |
| Manufacturer Address | 1221 CROSSMAN AVE SUNNYVALE CA 94089 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-05 |