MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK GREENFIELD?; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number M001505010

Device Problem Positioning Failure (1158)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

It was reported that an undeployed ivc filter was left in the patient.The patient presented with an occluded femoral artery.It was noted that a greenfield¿ivc filter was undeployed and had been left in the patient for an unknown reason by another facility.Two weeks ago, the patient underwent surgery for a femoral embolectomy.The undeployed ivc filter was not removed during surgery and stayed in place in the right iliac vein.No further patient complications were reported and the patient's current status is fine.

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: GREENFIELD?
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4210615
• MDR Text Key: 4965851
• Report Number: 2134265-2014-06653
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K955396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• 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?: Yes
• Date Manufacturer Received: 10/07/2014
• 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