MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for BIOSENSE CARTO 3 SYSTEM manufactured by Biosense Webster.
[55256458]
During a cardiac ablation procedure, the biosense carto 3 system mapping system malfunctioned causing the surgical procedure to be aborted prior to its completion. Diagnosis or reason for use: directs the surgeon where to go. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064848 |
| MDR Report Key | 5962894 |
| Date Received | 2016-09-16 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-08-23 |
| Date Added to Maude | 2016-09-20 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOSENSE CARTO 3 SYSTEM |
| Generic Name | BIOSENSE CARTO 3 SYSTEM |
| Product Code | DRQ |
| Date Received | 2016-09-16 |
| Returned To Mfg | 2016-08-23 |
| Model Number | CARTO 3 SYSTEM |
| Lot Number | 13457 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSENSE WEBSTER |
| Manufacturer Address | DIAMOND BAR CA 91765 US 91765 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-09-16 |