MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-07-10 for ULTRACINCH LP, 10 CELL, UC-LP-10 12545 manufactured by St. Jude Medical.
[2769994]
Same case as mfr report #300387001-2012-00003. It was reported during an ablation procedure using an epicor ultracinch lp the pt experienced a tear in the right atrial appendage. The physician noted an error message during an ablation procedure that read "damaged disposable detected". The cables and connections were inspected, revealing no corrosion or damage. The cables were exchanged and connected and the saline flow was checked, revealing no air bubbles. A second error message triggered, reading "power delivery out of range". The saline bag was then compressed to verify flow and the system was inspected for air bubbles, revealing none. The physician attempted to initiate therapy again but the error "power delivery out of range" continued, only allowing the unit to run for 3 seconds at a time. A second device was used and the same error message was displayed. After the use of both devices, a tear in the right atrial appendage was noted. The physician indicated the right atrial appendage was torn due to the trauma of passing the sizing system around the atrium numerous times. The case was successfully completed with no alarms using a (b)(4). The pt was in stable condition and at the time of this report remained in the post-operative ward with no delay in discharge due to this event.
Patient Sequence No: 1, Text Type: D, B5
[10052473]
The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant info from the review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2012-00002 |
| MDR Report Key | 2657241 |
| Report Source | 01,05,07 |
| Date Received | 2012-07-10 |
| Date of Report | 2012-06-29 |
| Date of Event | 2012-06-29 |
| Date Mfgr Received | 2012-06-29 |
| Date Added to Maude | 2012-07-18 |
| 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 | 0 |
| Manufacturer Contact | SETH KERSTEN |
| 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 | ULTRASONIC SURGICAL INSTRUMENT |
| Product Code | NTB |
| Date Received | 2012-07-10 |
| Model Number | 12545 |
| Lot Number | 26645 |
| 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 | 1. Required No Informationntervention | 2012-07-10 |