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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION GREENFIELD FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
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.

 
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Brand NameGREENFIELD
Type of DeviceFILTER, 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 Key11796595
MDR Text Key249670279
Report Number2134265-2021-05855
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK964284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/01/2004
Device MODEL Number43335
Device Catalogue Number43335
Device LOT Number0003870280
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2001
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/10/2021 Patient Sequence Number: 1
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