MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-03-19 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.
[1062035]
It was reported the ultrawand device created steam from behind the heart during ablation. The surgeon removed the ultrawand device while ablation algorithm was still running and noted that the saline was boiling. The ablation control system (acs) displayed a temperature of 80c. The surgeon inspected the site and the anesthesiologist monitored the electrocardiogram after discontinuing cardiopulmonary bypass and monitored pressures throughout the case. There were no reported patient consequences. The surgeon stated that if he had held the ultrawand down any longer, the patient would have been at risk.
Patient Sequence No: 1, Text Type: D, B5
[8257761]
St. Jude medical is in the process of investigating this event. Once the investigation has been completed, a followup report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00001 |
| MDR Report Key | 1346920 |
| Report Source | 05,06,07 |
| Date Received | 2009-03-19 |
| Date of Report | 2009-03-19 |
| Date of Event | 2009-03-16 |
| Date Facility Aware | 2009-03-16 |
| Date Mfgr Received | 2009-03-16 |
| Date Added to Maude | 2010-10-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PHYLLIS PIET-HUGHES |
| Manufacturer Street | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal | 55345 |
| Manufacturer Phone | 9529334700 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 240 SANTA ANA COURT |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAWAND LP |
| Generic Name | ULTRAWAND LP |
| Product Code | NTB |
| Date Received | 2009-03-19 |
| Model Number | NA |
| Catalog Number | 12400 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-19 |