ULTRA ICE PLUS¿
Received May 22, 2018
Report 2134265-2018-04816 · MDR key 7534283
Device
Generic name
Catheter, Ultrasound, Intracardiac
Manufacturer
Boston Scientific - Costa Rica (coyol)Model number
M00499120Catalog number
9912
Lot number
21851823
Product problems
- Device Contaminated During Manufacture or Shipping
- Device Contaminated During Manufacture or Shipping
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4)
Description of Event or Problem
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND ON THE DEVICE. UPON UNPACKING OF THE ULTRA ICE PLUS¿ FROM THE PACKAGING, A HAIR WAS NOTED ON THE DEVICE. THE CATHETER DID NOT COME IN CONTACT WITH THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT'S CONDITION IS FINE.
Additional Manufacturer Narrative
UPDATED: DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULTS CODES, CONCLUSION CODES, DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE. DEVICE EVALUATED BY MANUFACTURER - ANALYSIS OF RETURNED PRODUCT REVEALED THAT THE DEVICE HAS A FOREIGN MATTER THAT WAS OBSERVED IN THE IMAGING WINDOW; NO OTHER VISUAL DAMAGES WERE ENCOUNTERED UPON VISUAL INSPECTION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION WAS UNABLE TO BE DETERMINED. UDI (B)(4). BSC ID # (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND ON THE DEVICE. UPON UNPACKING OF THE ULTRA ICE PLUS¿ FROM THE PACKAGING, A HAIR WAS NOTED ON THE DEVICE. THE CATHETER DID NOT COME IN CONTACT WITH THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT'S CONDITION IS FINE.