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); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that only the main coil was returned for this complaint.The main coil returned was found kinked and stretched.Microscopic inspection revealed no damages were found on the both zap tip of the main coil.Dimensional inspection revealed that the apex zap tip, base zap tip and primary coil matches the specification.However, fibers bundles were loss due to coil condition.
Event or Problem Description
Reportable based on device analysis completed on 01sep2020.It was reported that the coil became stuck in its sheath.The target lesion area was located in the left common iliac artery.A 5mm/5.5 mm vortx diamond -18 was selected for use in a liver chemoembolization.During preparation, after the device was flushed, the coil got stuck in its sheath and part of the coil stretched from out side.The coil and the microcatheter were pulled.The procedure was completed with another of the same device.No complications reported.The patient is stable post procedure.However, device analysis revealed incomplete fiber bundles.

• 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: 10541953
• Report Number: 2134265-2020-12787
• Device Sequence Number: 304721
• Product Code: KRD
• UDI-Device Identifier: 08714729324898
• UDI-Public: 08714729324898
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 09/16/2020

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: 04/29/2022
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0023874924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RENEGADE MICROCATHETER
• Patient Age: 50 YR
• Patient Weight: 70