MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-28 for VAXCEL MINI-STICK KIT - 4 FRENCH 45-987 manufactured by Boston Scientific.
[351496]
This event involves a patient who was scheduled for an a-v, arterio-venous, fistulogram because of a clotted fistula. Two of the 4 french ministick sheaths failed when they were being inserted over the guidewire. The tips became burred and could not enter the vessels. A third kit was opened and performed properly. The case proceeded and was completed with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 553040 |
| MDR Report Key | 553040 |
| Date Received | 2004-10-28 |
| Date of Report | 2004-09-23 |
| Date of Event | 2004-08-26 |
| Report Date | 2004-09-23 |
| Date Reported to FDA | 2004-10-28 |
| Date Added to Maude | 2004-11-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAXCEL MINI-STICK KIT - 4 FRENCH |
| Generic Name | COAXIAL DILATOR SET |
| Product Code | GCC |
| Date Received | 2004-10-28 |
| Model Number | 45-987 |
| Catalog Number | 45-987 |
| Lot Number | 6808434 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 542588 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PL. NATICK MA 01760 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-28 |