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 2008-10-20 for ULTRAWAND HARMONIZED, UW-2, COMMERCIAL MOLD HANDLE 11709 manufactured by St. Jude Medical.
[980383]
The physician reported that this pt, status-post failed catheter-based procedures for atrial fibrillation, underwent mitral and tricuspid valve replacement in 2008. Before the valve procedures, the physician used the epicor ablation control system to treat the pt's atrial arrhythmia. Pulmonary vein isolation was conducted without incident and the pt converted to sinus rhythm. The physician then proceeded with the ultrawand ablation and reported that, approx thirty seconds into the procedure, he felt the wand get hot in his hand and there "was a pop, like an arc," and he immediately had the circulator stop the generator. He examined the back of the heart and saw nothing unusual where he had "ablated on the ventricle. " he proceeded with the rest of the case. Later that evening, he was called to see the pt in the icu where he had to open her chest and found that she had exsanguinated from a laceration to the posterior left ventricle. An ultracinch 11 device was also used during the procedure. It was reported that the ultracinch and ultrawand devices were discarded at the hospital. Reportedly, no post-mortem was conducted.
Patient Sequence No: 1, Text Type: D, B5
[8216450]
The device was not returned for analysis. Based on the info contained in the data down load, the ablation control system is functioning as intended. The acoustic power measurements are within target limits and the temperatures are being measured accurately. The acs appropriately turned off acoustic power to the ultrawand device when the measured temperature reached 100 deg c. The internal calibration and function checks of the acs all match to within 3% of the original measurements taken in 2007. The acs appropriately delivered alarm messages when saline irrigation pressure was outside of acceptable limits. The ultrawand and ultracinch devices were discarded at the hospital. The cause for the reported laceration and subsequent patient death remains unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2008-00006 |
| MDR Report Key | 1205872 |
| Report Source | 05,06,07 |
| Date Received | 2008-10-20 |
| Date of Report | 2008-10-17 |
| Date of Event | 2008-10-09 |
| Date Facility Aware | 2008-10-09 |
| Date Mfgr Received | 2008-10-11 |
| Date Added to Maude | 2008-10-27 |
| 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 | 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 HARMONIZED, UW-2, COMMERCIAL MOLD HANDLE |
| Generic Name | ULTRAWAND HARMONIZED |
| Product Code | NTB |
| Date Received | 2008-10-20 |
| Model Number | NA |
| Catalog Number | 11709 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1255040 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-10-20 |