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

Model Number 43335

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 07/12/2019

Event Type  Injury  

Event Description

On (b)(6) 2001, the patient was surgically implanted with a greenfield stainless steel vena cava filter.On (b)(6) 2019, the patient underwent a surgical procedure to remove the greenfield filter due to intermittent left back/flank pain, chronic swelling and pain of lower limb extremities (lle).The procedure required advanced complex techniques that prolonged the procedure.A 9 french sheath was unable to dislodge the filter, so a 16 french light laser sheath was used along with a pulsed laser.The filter and sheath were both removed from the patient.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11796595
• MDR Text Key: 249670279
• Report Number: 2134265-2021-05855
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 08714729070276
• UDI-Public: 08714729070276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2004
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0003870280
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2001
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention