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

Model Number	82875
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9304420
• Report Number: 2134265-2019-13630
• Device Sequence Number: 16687518
• Product Code: KRD
• UDI-Device Identifier: 08714729324898
• UDI-Public: 08714729324898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1