ULTRA ICE PLUS¿
Report
- Report Number
- 2134265-2018-04816
- Event Type
- Malfunction
- Date Received
- May 22, 2018
- Report Date
- May 2, 2018
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA (COYOL)
- Product Code
- DXK
- PMA / PMN Number
- K160173
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
(B)(4)
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).
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377115 | ULTRA ICE PLUS¿ | CATHETER, ULTRASOUND, INTRACARDIAC | DXK | BOSTON SCIENTIFIC - COSTA RICA (COYOL) | M00499120 | 21851823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |