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 2009-08-28 for ULTRACINCH LP, 10 CELL, UC-LP-10 12545 manufactured by St. Jude Medical.
[1153616]
It was reported that when the ultracinch device was connected, an error message was noted indicating cells one through nine were damaged. The device was reconnected to the cable and no error occurred. Ablation began and everything progressed with the staff running the case while the sjm representative spoke with the surgeon. The sjm representative paused the system several times due to the system only ablating at cell 10. The cables were checked and the physician started ablating with no change. The procedure/system was paused a final time to shut down the procedure/system and exchange the ultracinch device. At that time, a perforation was noticed by the physician at the left superior pulmonary vein. The left superior pulmonary vein was repaired and the procedure was stopped. The pt developed a svt after surgery that was not their before case. The pt returned to normal sinus rhythm the following day.
Patient Sequence No: 1, Text Type: D, B5
[8277822]
We are awaiting device return. A follow up med watch report will be submitted upon completion of the investigation. Date report submitted to fda by manufacturer: 8/28/2009. Date initial reporter provided the info to the manufacturer: 8/5/2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00008 |
| MDR Report Key | 1457314 |
| Report Source | 05,06,07 |
| Date Received | 2009-08-28 |
| Date of Report | 2009-08-05 |
| Date of Event | 2009-08-05 |
| Date Facility Aware | 2009-08-05 |
| Date Mfgr Received | 2009-08-06 |
| Date Added to Maude | 2009-09-01 |
| 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 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 | ULTRACINCH LP, 10 CELL, UC-LP-10 |
| Generic Name | ULTRACINCH LP, 10 CELL |
| Product Code | NTB |
| Date Received | 2009-08-28 |
| Model Number | NA |
| Catalog Number | 12545 |
| 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 | 1. Other | 2009-08-28 |