MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-06-22 for ULTEGRA RPFA-TRAP 85013 INSTR. manufactured by Accumetrics.
[18329931]
A manufacturer's field rep was demonstrating the ultegra rpfa-trap to a dr using a blood sample obtained from a pt who had not received a gp llb/llla inhibitor drug. A test result of a "pau" was obtained. A second blood sample was drawn from the arterial sheath, and the test result was 14 pau. These results are lower that the baseline (pre-drug) reference range cited in the device package insert (125 - 330 pau). The physician decided not to administer gp llb/llla inhibitor drug in conjunction with the angioplasty procedure. After the procedure, a third blood sample was taken, and a test result of 210 pau was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031760-2000-00006 |
| MDR Report Key | 283546 |
| Report Source | 07 |
| Date Received | 2000-06-22 |
| Date of Report | 2000-06-22 |
| Date of Event | 2000-05-23 |
| Date Mfgr Received | 2000-05-23 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2000-06-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BARBARA STEVENS |
| Manufacturer Street | 3985 SORRENTO VALLEY BOULEVARD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586431600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTEGRA RPFA-TRAP |
| Generic Name | PLATELET FUNCTION ASSAY |
| Product Code | JOZ |
| Date Received | 2000-06-22 |
| Model Number | NA |
| Catalog Number | 85013 INSTR. |
| Lot Number | W03876, W03893A |
| ID Number | 85011 CARTRIDGE |
| Device Expiration Date | 2000-09-20 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 274388 |
| Manufacturer | ACCUMETRICS |
| Manufacturer Address | 3985 SORRENTO VALLEY BOULEVARD SAN DIEGO CA 92121 US |
| Baseline Brand Name | ULTEGRA RPFA-TRAP |
| Baseline Generic Name | PLATELET FUNCTION ASSAY |
| Baseline Catalog No | 85013 INSTR. |
| Baseline ID | 85011 CARTRIDGE |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 6 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K992531 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-06-22 |