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

Device Problem Break (1069)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event approximated since unknown.(b)(6).

Event Description

It was reported that issues occurred with the greenfield filter.In a physician's clinical experience, he has encountered fractured, perforated and penetrated greenfield filters causing chronic severe abdominal pain, hemorrhage and serious bodily harm.No additional specific information is known at this time.

• 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 CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8597066
• MDR Text Key: 144615196
• Report Number: 2134265-2019-05060
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other