ULTRA ICE PLUS¿
Received Mar 22, 2018 · Event occurred Feb 20, 2018
Report 2134265-2018-02275 · MDR key 7362456
Device
Generic name
Catheter, Ultrasound, Intracardiac
Manufacturer
Boston Scientific - Costa Rica (coyol)Model number
M00499120Catalog number
9912
Lot number
20881358
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AGE AT TIME OF EVENT : OVER 18 YEARS. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE A FOREIGN SUBSTANCE WAS NOTED. AN ULTRA ICE PLUS IMAGING CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STERILE WATER INJECTED TO THE TIP OF THE CATHETER LOOKED CLOUDY. FURTHERMORE, THE DEVICE WAS INSERTED TO THE PATIENT'S BODY BUT PHYSICIAN DISCONTINUED THE USAGE AND REMOVED THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.
Additional Manufacturer Narrative
DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. NO ISSUES WERE NOTED UPON VISUAL INSPECTION. THE CATHETER WAS FLUSHED NORMALLY UPON FUNCTIONAL INSPECTION AND NO ISSUES WERE NOTED. THE IMPEDANCE TESTING SHOWED A GOOD UNIT WAVE FORM. GOOD SQUARE IMAGE APPEARED IN THE ILAB SYSTEM UPON IMAGE CHARACTERIZATION TESTING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS NOT CONFIRMED - RETURNED AS THERE WAS NO EVIDENCE OF EITHER THE ALLEGED ISSUE(S) OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE A FOREIGN SUBSTANCE WAS NOTED. AN ULTRA ICE PLUS IMAGING CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STERILE WATER INJECTED TO THE TIP OF THE CATHETER LOOKED CLOUDY. FURTHERMORE, THE DEVICE WAS INSERTED TO THE PATIENT'S BODY BUT PHYSICIAN DISCONTINUED THE USAGE AND REMOVED THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.