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

Model Number	82865
Medical Device Problem Codes	Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the main coil was returned for this complaint.The coil was returned semi inside of coil introducer.The coil plunger was returned, and no damages were noticed.The main coil returned was found kinked and stretched.Also, both zap tips of the coil were detached.No more damages were found in the device.Microscopic inspection of the main coil revealed that the zap tip was inspected, and both (proximal and distal) were detached parts were not returned.Dimensional inspection of the main coil revealed the components were within specification.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that the coil could not be pushed from the catheter and the tail end of the coil was folded.The target lesion was located in the chest.A 5mm/5.5mm vortx-18 was selected for use.During preparation, it was noted that the coil could not be pushed from the catheter, the tail end of the coil was folded.The procedure was completed with another of the same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that the zap tips of the main coil were 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: 11996888
• Report Number: 2134265-2021-07681
• Device Sequence Number: 1008977
• Product Code: KRD
• UDI-Device Identifier: 08714729158899
• UDI-Public: 08714729158899
• 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): 06/14/2021

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: 06/15/2023
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0025717432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR