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

Model Number	82865
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: only the main coil was returned for analysis and investigation was completed on 30mar2022.Visual inspection revealed that the main coil was kinked and stretched.Microscopic inspection revealed that both zap tips were inspected, and no damages were found.Dimensional inspection revealed that both zap tip and primary coil are within specification, however, number of fiber bundles did not match with the specification.
Event or Problem Description
Reportable based on device analysis completed on 30mar2022.It was reported that the coil was stretched.The target lesion was located in the vessel of the lung.A 6mm/6.5 mm vortx - 18 embolics was selected for use.During preparation, it was noted that the coil was stretched and was not successfully deployed.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, device investigations revealed that there were missing fiber bundles.

• Brand Name: VORTX - 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: 14187126
• Report Number: 2134265-2022-04005
• Device Sequence Number: 5932839
• Product Code: KRD
• UDI-Device Identifier: 08714729201199
• UDI-Public: 08714729201199
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/22/2022

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: 05/24/2023
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0025633342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 60 KG