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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK GREENFIELD¿ FILTER, INTRAVASCULAR, CARDIOVASCULAR

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BOSTON SCIENTIFIC - CORK GREENFIELD¿ FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number M001503000
Device Problems Filter (816); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the filter did not open. A greenfield was advanced and deployed; however, the filter did not open. The following day, the filter was removed in a collapsed state.

 
Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned to site for analysis. The filter was examined and there was found to be thrombus around the bottom of the filter, binding the legs together. The filter was placed in hot water for an hour in an attempt to remove the thrombus and open the filter legs however this was not possible. The filter was then placed in water for a further 48 hours in an attempt to remove the thrombus and open the filter legs however this was still not possible. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

 
Event Description

It was reported that the filter did not open. A greenfield was advanced and deployed; however, the filter did not open. The following day, the filter was removed in a collapsed state.

 
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Brand NameGREENFIELD¿
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5457864
MDR Text Key38963040
Report Number2134265-2016-00923
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK901659
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 01/26/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2017
Device MODEL NumberM001503000
Device Catalogue Number50-300
Device LOT Number17595908
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/03/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/27/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/24/2016 Patient Sequence Number: 1
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