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

Model Number M001503010

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that during a filter placement procedure, the cannula became kinked.Vascular access was obtained via the femoral artery.This 12 fr greenfield¿ filter was selected and was advanced into an unspecified lesion with no issues noted.It was placed well superior to the markers, the dilators and the greenfield filter worked efficiently.The dilator catheter that goes up the wire passed with no problem.When the trocar of the catheter was taken out and the filter device was placed into the lumen of the cannula, it advanced maybe 40cm and then would not go any further.Under fluoroscopy they saw a kink in the cannula (the introducer cannula) and filter itself would not pass further than that and this happened on both pieces of equipment.It was noted that it happened in the exact same way both times during the same case and same patient.They withdrew and placed a greenfield filter in the jugular vein approach and both femoral kits were defective.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that no filter was present in the capsule.

Manufacturer Narrative

Device evaluated by manufacturer: examination of the returned complaint device revealed that the blue jugular dilator sheath was kinked.The release tab on the carrier was in the unlocked position and the stopcock was in the open position.No filter was present in the capsule.A kinked was found on the carrier distal to the capsule.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3988340
• MDR Text Key: 20453529
• Report Number: 2134265-2014-05124
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901659
• 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: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: M001503010
• Device Catalogue Number: 50-301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1