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 2009-06-15 for ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, 11 CELL 12546 manufactured by St. Jude Medical.
[22119552]
We are in the process of investigating this event. A follow up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[22121621]
It was reported the physician attempted to do an ablation with an ultracinch lp device. The device was prepped according to the ifu and passed around the left atrium without difficulty. Approximately 3 minutes into the ablation, an error message on the acs indicating damaged disposable - cell 10 out of range was displayed. The sjm rep attempted to disconnect and reconnect the cable which did not resolve the problem. The ablation was continued without cell 10. The surgeon then attempted to ablate with the wand and heard popping. About one minute into the ablation the surgeon noted steam and heated saline flowing from the wand, at which point he elected to pause the ablation, after about 2 minutes and after confirming that the cells were free of air, he proceeded to perform an additional 30 second ablation. The physician told the sjm rep he felt the wand was dangerous and that one needs to be careful when using it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003870001-2009-00006 |
| MDR Report Key | 1471725 |
| Report Source | 05,06,07 |
| Date Received | 2009-06-15 |
| Date of Report | 2009-06-15 |
| Date of Event | 2009-06-08 |
| Date Facility Aware | 2009-06-08 |
| Date Mfgr Received | 2009-06-09 |
| Date Added to Maude | 2009-10-20 |
| 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 | ONE ST. JUDE MEDICAL DR. |
| 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 | ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, 11 CELL |
| Generic Name | ULTRACINCH, UC-LP-11 |
| Product Code | NTB |
| Date Received | 2009-06-15 |
| Model Number | NA |
| Catalog Number | 12546 |
| 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 | 2009-06-15 |