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

Model Number	43175
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2008
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the filter was not completely opened.On (b)(6) 2008 that two greenfield ivc filters were implanted.Access was obtained via the right internal jugular vein.An introducer catheter and a j-wire were advanced to the superior vena cava via fluoroscopic guidance.A dilator was passed over the guidewire and an attempt were made to remove the initial short guidewire for a longer guidewire.Repeated attempts were made to advance the dilator over the guidewire and into the superior and inferior vena cava.After multiple attempts the long guidewire was replaced with the initial short guidewire which was advanced into the inferior vena cava and the dilator was advanced through the atrium and into the inferior vena cava.The greenfield filter sheath and dilator were passed over the guidewire and advanced through the inferior vena cava to the bifurcation.The dilator and guidewire were removed and the introducer carrying the filter was passed through the sheath to in the inferior vena cava.The filter was discharged inferior to the l3-l4 vertebra, therefore a second ivc filter was placed through the sheath to the l2-l3 level and was discharged.The second filter was angulated, and the feet of the filter did not all appear to be deployed properly; however, the filter seemed to be fixed in position.The patient was bleeding from stentomy site where the dilator had entered and where a triple lumen line had been placed.Pressure was maintained to secure the bleeding.The procedure was tolerated satisfactorily.

• 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: 9995756
• Report Number: 2134265-2020-05588
• Device Sequence Number: 3699866
• Product Code: DTK
• UDI-Device Identifier: 08714729114659
• UDI-Public: 08714729114659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K901659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2020

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: 12/03/2007
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0007196480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/24/2020
• Patient Sequence Number: 1
• Patient Age: 45 YR