ULTRA ICE PLUS¿
Received Mar 6, 2018
Report 2134265-2018-01394 · MDR key 7315860
Device
Generic name
Catheter, Ultrasound, Intracardiac
Manufacturer
Boston Scientific - Costa Rica (coyol)Model number
M00499120Catalog number
9912
Lot number
0021395014
Product problems
- Device Packaging Compromised
- Device Packaging Compromised
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DEVICE PACKAGING WAS COMPROMISED. DURING UNPACKING OF THE ULTRA ICE PLUS¿ IMAGING CATHETER A 1 CM SLIT WAS FOUND IN THE PART WHERE IT WILL BE OPENED. NO PATIENT INVOLVEMENT AS THE DEVICE COULD NOT BE DELIVERED.
Additional Manufacturer Narrative
DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE RETURNED IN THE ORIGINAL BOX, THE BOX WAS ALREADY OPENED FORM THE CLOSURE STRIP. A SIDE EDGE OF THE HAS A DAMAGE SECTION, HOWEVER, THIS DAMAGE DOES NOT PASS THROUGH THE BOX CARTON, IT'S A DAMAGE IN THE SURFACE OF THE BOX. INSIDE THE BOX ALL THE COMPONENTS AND THE DEVICE WERE IN THEIR SEALED POUCH AND WAS NOT DAMAGE ON THEM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS HANDLING DAMAGE AS THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE OR PORTION OF THE DEVICE WITHOUT DIRECT PATIENT CONTACT. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DEVICE PACKAGING WAS COMPROMISED. DURING UNPACKING OF THE ULTRA ICE PLUS¿ IMAGING CATHETER A 1 CM SLIT WAS FOUND IN THE PART WHERE IT WILL BE OPENED. NO PATIENT INVOLVEMENT AS THE DEVICE COULD NOT BE DELIVERED.