MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-06 for ENSITE VELOCITY? DWS7 V.5.0.1 100149280 EE3000 manufactured by St. Jude Medical, Inc..
[177997931]
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[177997932]
Related manufacturer reference: 3008452825-2020-00073, 3008452825-2020-00066. During a premature ventricular contraction procedure, a cancellation, tamponade and subsequent death occurred. The cs catheter and the his catheter were introduced via the femoral vein into the coronary sinus and at the his bundle. During introduction, excessive catheter movement was observed. A flexibility was introduced via retrograde access into the aorta, and the latmap and a geometry of the lvot was collected. System reference and respiration compensation were utilized and the update respiration was off. Ablation was started at the earliest point in the lvot. Due to the catheter movement, the cs 5 was utilized for reference. Flouro was not used to locate the catheters following the shift. During preparation of changing from arterial access to venous access the physician noticed abnormal steering of the flexibility. Following ablation in the lvot, there were still pvcs. The visualization of the ablation catheter was not in the correct location, and system reference was utilized and a shift occurred. The cs shadow and current cs position were not aligned. The physician decided to go in rvot and a flexibility was introduced. A model of rvot and latmap was collected. The ablation of the earliest point in rvot was started and pvcs were still present. Due to the shift, the procedure was not completed. The shift was due to instability of the ensite system or the patient, which is why they procedure was not completed. Following the procedure, in the recovery room, the patient noted feeling of nausea. An echocardiogram confirmed a tamponade located mainly rn/ra and was circular, and a pericardiocentesis was performed. The coronary sinus catheter (inquiry) was the physician's suspected cause for the tamponade. During treatment of tamponade resuscitation was necessary. The patient was deceased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2020-00014 |
| MDR Report Key | 9677256 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2016-10-10 |
| Date Added to Maude | 2020-02-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. (AF-ST. PAUL) |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENSITE VELOCITY? DWS7 V.5.0.1 |
| Generic Name | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| Product Code | DQK |
| Date Received | 2020-02-06 |
| Model Number | 100149280 |
| Catalog Number | EE3000 |
| Lot Number | 5726265 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-06 |