MalfunctionNTB
ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, UC-LP-9
Received Nov 10, 2010 · Event occurred Oct 14, 2010
Report 3003870001-2010-00013 · MDR key 1907130
Device
Product problems
- Disconnection
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(4) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.
Description of Event or Problem
IT WAS REPORTED DURING ABLATION, THE PHYSICIAN NOTICED THAT THE PLASTIC SLEEVE AROUND THE ELECTRICAL CABLE AND RINSING TUBES DISCONNECTED FROM THE CINCH. THE PROXIMAL CONNECTOR MOVED BELOW THE SVC SO AFTER COMPLETE ABLATION, THE ELECTRICAL CABLE HAD TO BE CUT RO REMOVE THE ULTRACINCH DEVICE. THERE WERE NO CONSEQUENCES TO THE PT.