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

Model Number	82875
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The coil plunger, the coil introducer and retaining clip were not returned.The main coil was returned for this complaint.The coil was kinked and stretched.No more damages were found in the returned device.Microscopic inspection on main coil was performed.Both zap tip shape and surface were smooth.Dimensional inspection on the main coil revealed that both zap tip od (outer diameter) and primary coil od were within specification.However, the number of fiber bundles were incomplete.
Event or Problem Description
Reportable based on device analysis completed on 11mar2022.It was reported that the coil was stuck inside the microcatheter.The target lesion was located in the renal area.A 18 3mm/3.3 mm vortx diamond-18 coil was selected for use.During the procedure, the device was intermittently hydrated.When the doctor attempted to push the device, the coil got stuck in the middle of the microcatheter and could not be pushed any further.The procedure was completed with a different device.No complications were reported and patient was doing good post procedure.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
• 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: 14026885
• Report Number: 2134265-2022-03243
• Device Sequence Number: 11411984
• Product Code: KRD
• UDI-Device Identifier: 08714729324874
• UDI-Public: 08714729324874
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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: 05/11/2024
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0027474558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male