N/A
Received Oct 5, 2009 · Event occurred Sep 3, 2009
Report 2090040-2009-00006 · MDR key 1490557
Device
Product problems
- Material Fragmentation
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING THE PROCEDURE, THE CATHETER BROKE INTO PIECES INSIDE THE PATIENT. A SECOND PROCEDURE WAS PERFORMED THE FOLLOWING DAY TO REMOVE THE PIECES FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
ASCENT HEALTHCARE SOLUTIONS RESTERILIZES THIS MODEL OF ANGIOGRAPHIC CATHETER THROUGH OUR OPEN/UNUSED PROCESS. HOWEVER, THE DEVICE WAS NOT RETURNED TO ASCENT FOR EVALUATION AND THE PACKAGING WAS NOT SAVED. IT WAS DETERMINED THAT THIS (B) (6) WAS NEVER SENT THIS ITEM NUMBER FROM ASCENT HEALTHCARE SOLUTION. HOWEVER, TWO OTHER FACILITIES IN (B) (6) NETWORK WERE SENT THIS ITEM IN THE PAST. PICTURES OF THE DEVICE IN THIS INCIDENT WERE PROVIDED, BUT DO NOT CONFIRM THE DEVICE WAS RESTERILIZED BY ASCENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, BECAUSE THE SALES ORDER INFORMATION WAS NOT PROVIDED. A REVIEW OF THE PROCEDURES RELATED TO OPEN/UNUSED DEVICE INSPECTION WAS PERFORMED AND THE PROCEDURES ARE APPROPRIATE.