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

Model Number	82865
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the coil, the retaining clip and the coil introducer were returned for this complaint.The coil was returned outside the coil introducer.The main coil returned was found kinked and stretched.The zap tip was detached and it was not returned.The retaining clip and the coil introducer were in good condition, no damages were found.Microscopic inspection of the main coil revealed that the zap tip was detached and it was not returned.Dimension inspection of the main coil revealed that the number of fiber bundles did not match with the specification.The fibers bundles were lost due to coil condition.
Event or Problem Description
Reportable based on device analysis completed on 05oct2020.It was reported that device could not be advanced.The target lesion area was located in the splenic artery.A 5mm/5.5 mm vortx-18 was selected for use.During embolization, the physician could not advance the coil through the microcatheter hub of a non-boston scientific device from the coil introducer.The procedure was completed with another of the same device.There were no complications and the patient's condition after the procedure is stable.However, device analysis revealed that there are missing fibers and the zap tip was detached.

• 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: 10701260
• Report Number: 2134265-2020-14420
• Device Sequence Number: 19653642
• Product Code: KRD
• UDI-Device Identifier: 08714729324867
• UDI-Public: 08714729324867
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/19/2020

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: 06/03/2021
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0022335414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1