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

Model Number	43335
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
In (b)(6) 2003 the patient underwent placement of a greenfield vena cava filter.In (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed the proximal tip of the filter was 6cm from left renal vein.There was normal alignment along axis.
Event or Problem Description
In (b)(6) 2003 the patient underwent placement of a greenfield vena cava filter.In (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed the proximal tip of the filter was 6cm from left renal vein.There was normal alignment along axis.It was further reported that the struts appeared normally oriented with no perforation of the vena cava or surrounding hollow or solid organs and no retroperitoneal mass or fluid collection.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9939107
• Report Number: 2134265-2020-04711
• Device Sequence Number: 13614112
• Product Code: DTK
• UDI-Device Identifier: 08714729070276
• UDI-Public: 08714729070276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2006
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0005410345
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR