IMAGER II
Received Dec 12, 2006 · Event occurred Nov 8, 2006
Report 6000093-2006-02586 · MDR key 796780
Device
Generic name
Dqc, Catheter, Intravascular, Diagnostic
Manufacturer
Boston Scientific Corp.Model number
NACatalog number
31-424
Lot number
0000039891
Product problems
- Unsealed Device Packaging
- Replace
- Sterility
Patient
*
- No Patient involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO A CAROTID ARTERY ANGIOGRAPHY DIAGNOSTIC PROCEDURE, THE PACKAGE SEAL WAS COMPROMISED. THE CUSTOMER REPORTED THAT, "WHEN THE NURSE CAME TO OPEN THE STERILE PACK ON THIS IMAGER CATHETER, SHE FOUND A GAP IN THE SEAL, WHICH THEREFORE COMPROMISED THE STERILITY OF THE PRODUCT. ANOTHER CATHETER WAS USED INSTEAD. " THE DEVICE HAD NO CONTACT WITH THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF THE DATE OF THIS REPORT.