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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC Back to Search Results
Model Number M00499120
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event : over 18 years. (b)(4).
 
Event Description
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.
 
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).
 
Event Description
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.
 
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Brand NameULTRA ICE PLUS¿
Type of DeviceCATHETER, ULTRASOUND, INTRACARDIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7362456
MDR Text Key103289246
Report Number2134265-2018-02275
Device Sequence Number1
Product Code DXK
UDI-Device Identifier08714729904380
UDI-Public08714729904380
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/13/2019
Device Model NumberM00499120
Device Catalogue Number9912
Device Lot Number20881358
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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