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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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.No more damages were found in the device.Microscopic inspection of main coil revealed that both zap tips were inspected, and no damages were found.Dimensional inspection of the main coil revealed the components were within specification except the number of fiber bundles, which were only 1 out of 25.The fiber bundles were lost due to the stretching condition.
Event or Problem Description
Reportable based on device analysis completed on 08jul2021.It was reported that the coil could not be delivered at halfway and sheath could not be pushed.The target lesion was located in the gastric artery.A 5mm/5.5mm vortx - 18 was selected for use.During the procedure, the coil could not be delivered at halfway, and the physician could not push sheath after many attempts.The device was simply pulled out and the procedure was completed with a different device.No patient complications were reported and patient was stable post procedure however, device analysis 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
• MDR Report Key: 12230291
• Report Number: 2134265-2021-09619
• Device Sequence Number: 3802067
• Product Code: KRD
• UDI-Device Identifier: 08714729324867
• UDI-Public: 08714729324867
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 02/16/2023
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0025371932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 50