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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 Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that device packaging was compromised. During unpacking of the ultra ice plus¿ imaging catheter a 1 cm slit was found in the part where it will be opened. No patient involvement as the device could not be delivered.
 
Manufacturer Narrative
Device evaluated by mfr. , eval summary attached, method codes, result codes, conclusion codes updated. Device evaluated by manufacturer: the device was returned for analysis. The device returned in the original box, the box was already opened form the closure strip. A side edge of the has a damage section, however, this damage does not pass through the box carton, it's a damage in the surface of the box. Inside the box all the components and the device were in their sealed pouch and was not damage on them. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact. (b)(4).
 
Event Description
It was reported that device packaging was compromised. During unpacking of the ultra ice plus¿ imaging catheter a 1 cm slit was found in the part where it will be opened. No patient involvement as the device could not be delivered.
 
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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 Key7315860
MDR Text Key101634879
Report Number2134265-2018-01394
Device Sequence Number1
Product Code DXK
Combination Product (y/n)N
PMA/PMN Number
K160173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/16/2019
Device Model NumberM00499120
Device Catalogue Number9912
Device Lot Number0021395014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2017
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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