MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GREENFIELD¿; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number M001505010

Device Problem Break (1069)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Event date: 2009.If implanted, give date: 1998.(b)(4).Device evaluated by mfr: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported the filter was broken.A greenfield filter was implanted in 1998.The patient underwent a mri in 2009 due to a bad hip.During the procedure, a leg of the greenfield filter "ripped" and "got hold in her back to her spinal cord." the patient reported a spinal fluid leak, difficulty breathing and pain in her chest, kidney, back and head.The patient has a surgery scheduled to remove blood clots from the filter and assess the broken filter.

• Brand Name: GREENFIELD¿
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6286192
• MDR Text Key: 66042504
• Report Number: 2134265-2017-00112
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001505010
• Device Catalogue Number: 50-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR