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

Model Number	82865
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coil fracture occurred.The target lesion area was located in a medium tortuous splenic artery.A 6mmx6.5mm vortex-18 was selected for use in arterial aneurysm embolization.During the procedure, the coil deployed in the lesion after tumor was reached by the delivery system.The coil could not deployed upon withdrawal and was detached.Subsequently, the interlocking arm of the coil was detached/unlocked from the pusher wire.The coil was simply removed with the catheter from the patient, and there were no device fragments left in the patient's body.The procedure was completed with another of the same device.No complications reported and the patient was stable.
Event or Problem Description
It was reported that coil fracture occurred.The target lesion area was located in a medium tortuous splenic artery.A 6mmx6.5mm vortx-18 was selected for use in arterial aneurysm embolization.During the procedure, the coil deployed in the lesion after tumor was reached by the delivery system.The coil could not deployed upon withdrawal and was detached.Subsequently, the interlocking arm of the coil was detached/unlocked from the pusher wire.The coil was simply removed with the catheter from the patient, and there were no device fragments left in the patient's body.The procedure was completed with another of the same device.No complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by the manufacturer: the device was returned for analysis.Only the main coil was returned.The coil introducer, coil plunger and retaining clip were not returned.The main coil returned was found unraveled, kinked and stretched.No more damages were found.The dimensional inspection revealed that the apex zap tip, base zap tip, outer diameter (od) of the primary coil were within it's specification.However, the fiber bundles were not within it's specification as some of the fiber bundles were missing.

• 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
• MDR Report Key: 8901821
• Report Number: 2134265-2019-09764
• Device Sequence Number: 2206214
• Product Code: KRD
• UDI-Device Identifier: 08714729158905
• UDI-Public: 08714729158905
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: 06/24/2020
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0020927103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 63