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

Model Number M001503000

Device Problem 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.

• Brand Name: GREENFIELD¿
• Type of Device: FILTER, 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 Key: 5457864
• MDR Text Key: 38963040
• Report Number: 2134265-2016-00923
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: M001503000
• Device Catalogue Number: 50-300
• Device Lot Number: 17595908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention