XPANDER II EU
Received Nov 19, 2013
Report 2953769-2013-00176 · MDR key 3477173
Device
Generic name
Calibrator For Cell Indices
Manufacturer
Kyphon NeuchatelCatalog number
KX153-C
Lot number
0006855134
Product problems
- Material Rupture
Patient
00077 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOO RUPTURED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Additional Manufacturer Narrative
(B)(4): ANALYSIS OF THE RETURNED ITEM SHOWS THAT DURING FUNCTIONAL ANALYSIS, AN ATTEMPT HAS BEEN DONE TO INFLATE THE BALLOON, BUT IT WAS NOT POSSIBLE, BECAUSE A LEAK APPEAR UNDER LOW PRESSURE. VISUAL ANALYSIS CONFIRMED THE LEAKAGE. A PIN HOLE HAS BEEN DISCOVER ON THE DISTAL PEAK OF THE BALLOON. NOTE THAT UNDER LOW PRESSURE, ONLY DROP COMES OUT FROM THIS HOLE AND IF THE PRESSURE IS HIGHER, A WATER SPRAY IS VISIBLE. BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE LEAKAGE IS ATTRIBUTED TO THE CONTACT WITH BONE SPLINTERS DURING SURGERY.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.