MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-07 for STEALTH 360 DEGREES 2.00 SOLID BURR PRD-SC30-200 manufactured by Csi - Cariovascular System Inc..
[4587984]
Guide wire was put through several right angle turns and somehow kinked and could not be removed from the patient. Patient was being treated in the cardiac cath lab and was taken to surgery for removal of guide wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037220 |
| MDR Report Key | 3929657 |
| Date Received | 2014-07-07 |
| Date of Report | 2014-07-07 |
| Date of Event | 2014-05-14 |
| Date Added to Maude | 2014-07-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | STEALTH 360 DEGREES 2.00 SOLID BURR |
| Generic Name | BURR |
| Product Code | HBG |
| Date Received | 2014-07-07 |
| Model Number | PRD-SC30-200 |
| Lot Number | 94401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CSI - CARIOVASCULAR SYSTEM INC. |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-07 |