THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER Adverse Event — Injury (MDR 2029046-2020-00577)
THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER Adverse Event — Injury (MDR 2029046-2020-00577) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; Generic name: CARDIAC ABLATION PERCUTANEOUS CATHETER; Manufa
| Device | THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER |
|---|---|
| Generic name | CARDIAC ABLATION PERCUTANEOUS CATHETER |
| Manufacturer | BIOSENSE WEBSTER INC |
| Report number | 2029046-2020-00577 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 8, 2020. THE PATIENT IS A 76-YEAR-OLD FEMALE PATIENT (40KG). PATIENT¿S CONDITION IS UNCHANGED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. THEREFORE, PROCESSED A2. PATIENT AGE AT THE TIME OF EVENT, A2. AGE UNIT, A3. SEX, A4. WEIGHT OF THE PATIENT AND A4. WEIGHT UNIT. IF ADDITIONAL INFORMATION IS RECEIVED |
| Source | openFDA MAUDE (device adverse events) |
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