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

Model Number 82875

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The main coil, the coil plunger and coil introducer were returned for this complaint.One section of the main coil was returned outside the coil introducer.The main coil returned was inspected and no damages were found.The coil plunger was advanced through the coil introducer without problems, no resistance was felt.The main coil was inspected and no damages were found.Dimensional inspection revealed that actual apex zap tip, base zap tip and primary coil (outer dimensional) were within ths specification.However, the fiber bundles were less than the specification.

Event Description

Reportable based on device analysis completed on 19oct2019.It was reported that coil did not come out of the sheath.A 5mm/5.5mm vortx diamond - 18 was selected for use.During preparation, it was noted that the coil could not pass through the introducer sheath.The procedure was completed with another of the same device.No complications reported.However, device analysis revealed that the fiber bundles were incomplete.

• Brand Name: VORTX DIAMOND - 18
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9304420
• MDR Text Key: 171649955
• Report Number: 2134265-2019-13630
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729324898
• UDI-Public: 08714729324898
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0020186750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• 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