MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK VORTX? - 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number M0013812060

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that the coil was out of the introducer.A 6mm/6.5 mm vortx - 18 was selected to treat the unspecified target lesion.During preparation, the device was unpacked and it was then noted that the coil was coming out of the coil introducer.The procedure was completed with a different device.No patient complications were reported and the patient's status is good.However, device analysis revealed that the number of fiber bundles was below the assigned specification.

Manufacturer Narrative

Device evaluated by mfr: a plunger, coil and introducer were returned for analysis.A visual examination identified the plunger was kinked.The apex zap tip was visible in the hub of the introducer.An attempt was made to advance the coil with the plunger through the introducer however this was not successful as resistance was met.The introducer had to be cut in order to retrieve the coil resulting in the coil being inadvertently cut while attempting to retrieve it.This left the apex zap tip and a section of the coil remaining in the hub of the introducer.This was retracted with ease and this part of the coil was found to be kinked and stretched from the procedure.There was blood on the apex zap tip and on the proximal fiber bundles, likely from handling.Microscopic inspection found no issues with the zap tips.The dimensions of the coil that could be measured were found to be in specification.The number of fiber bundles recorded during product analysis was below the assigned specification.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 without direct patient contact.(b)(4).

• Brand Name: VORTX? - 18
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 3810034
• MDR Text Key: 19717315
• Report Number: 2134265-2014-02683
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• PMA/PMN Number: K914786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: M0013812060
• Device Catalogue Number: 381206
• Device Lot Number: 14699665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2011
• 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