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 2009-11-04 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.
[20347080]
It was reported that the ultrawand device became warm in the physician's hand during the ablation with about 15 seconds left to the end of the ablation set. The ablation was paused at the 11 seconds to go mark and the irrigation flow was increased from 120 ml/min to 300 ml/min. The surgeon paused the ablation before any damage could occur to the patient, waited for the system to cool, and restarted the ablation with 11 seconds left to go. He did not feel the wand getting warm after that point. The device was discarded at the hospital. The physician was concerned that the patient side of the wand could be getting warmer than desired, because the back of the wand was so warm. He did not remove the wand from behind the heart, but did remove his hand. He believes that the patient was not in any real danger, but that this is a problem that should be addressed.
Patient Sequence No: 1, Text Type: D, B5
[20554916]
The device was not returned for analysis and review of the device history record was not possible as the serial number is unknown. Animal studies have demonstrated that audible saline boiling (popping sound) can occur if any cell loses contact with the tissue during ablation, and has not resulted in tissue damage. Audible saline boiling can also occur if the wand is pressed too hard against the tissue, which slows or stops the flow of saline through one or both cells and results in conductive tissue heating. There were no reported consequences to the patient. A precaution has been added to the epicor ultrawand lp instructions for use (ifu) that states "applying excessive pressure to the device may temporarily decrease saline flow by collapsing or blocking the saline irrigation membranes, resulting in a decrease of acoustic coupling and an increase in heat conducted from the ablation array.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00010 |
| MDR Report Key | 1542353 |
| Report Source | 05,06,07 |
| Date Received | 2009-11-04 |
| Date of Report | 2009-11-04 |
| Date of Event | 2009-04-06 |
| Date Facility Aware | 2009-04-06 |
| Date Mfgr Received | 2009-04-06 |
| Date Added to Maude | 2010-08-19 |
| 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 | 3 |
| Manufacturer Contact | KAREN MCKELVEY |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517562000 |
| 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 | 2009-11-04 |
| Model Number | NA |
| Catalog Number | 12400 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-04 |