MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 43335

Device Problem Positioning Failure (1158)

Patient Problem Injury (2348)

Event Date 08/30/2019

Event Type  Injury  

Event Description

In (b)(6)1998 the patient underwent placement of a greenfield vena cava filter.In (b)(6) 2019 a computed tomography (ct) scan revealed the filter appeared to be in a satisfactory position, however there was an additional filter which did not deploy; identified within the right iliac vein.

Event Description

In (b)(6) 1998 the patient underwent placement of a greenfield vena cava filter.In (b)(6) 2019 a computed tomography (ct) scan revealed the filter appeared to be in a satisfactory position, however there was an additional filter which did not deploy; identified within the right iliac vein.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9938839
• MDR Text Key: 187199612
• Report Number: 2134265-2020-04708
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 08714729070276
• UDI-Public: 08714729070276
• Combination Product (y/n): N
• PMA/PMN Number: K964284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2001
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0001266221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR