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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 Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
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.
 
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).
 
Event Description
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.
 
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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 Key7534283
MDR Text Key108992097
Report Number2134265-2018-04816
Device Sequence Number1
Product Code DXK
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 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/11/2020
Device Model NumberM00499120
Device Catalogue Number9912
Device Lot Number21851823
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2018
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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