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

Model Number M001504000

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

Reportable based on returned device analysis completed (b)(4) 2015.It was reported that the filter would not deploy.The greenfield¿ was advanced.When they went to deploy the filter, the device got hung up in the delivery system.It got stuck and wouldn't release and wouldn't deploy.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.Returned device analysis revealed the filter was deployed.

Manufacturer Narrative

Device evaluated by mfr: the introducer catheter, blue dilator, blue braided sheath and the filter was returned to site for analysis.The filter was returned outside of the capsule.The lot number was confirmed from the packaging.The filter was placed in the stainless steel template and the diameter of the filters legs were out of specification.It is most probable that during transit of the device back to site for analysis, the filter was damaged from its original shape as the filter was not protected during shipping.The length of the filter was in specification.Analysis of the returned introducer catheter revealed the paper safety sleeve was removed; around the handle of the introducer catheter and that the trigger (thumb switch) had been unlocked and moved down the deployment track.The trigger was placed back in a locked position.A kink was noted in the introducer sheath 5.5cm proximal the hub of the introducer sheath.The length of the introducer sheath was measured and met specification.The capsule was examined for any damage and no issues were noted.The length of the blue braided sheath was measured and met specification.The manufacturing batch record review confirmed the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(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: 4455702
• MDR Text Key: 18896282
• Report Number: 2134265-2015-00112
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964284
• 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: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: M001504000
• Device Catalogue Number: 50-400
• Device Lot Number: 0017042738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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