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	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Only the main coil, retaining clip and coil plunger were returned for this complaint and no damages were noticed.The coil introducer did not return.The main coil returned was found kinked and stretched.Also, a zap tip of the coil was detached.Microscopic inspection of the main coil revealed that the zap tip was inspected and was found detached (part was not returned).Dimensional inspection of the main coil that could be measured were performed and were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 31aug2021.It was reported that the coil could not be delivered.The target lesion was located in a pulmonary nodule.A 5 mm/ 5.5 mm vortx - 18 was selected for use.During the procedure, it was noted that the coil could not be delivered and failed to advance the coil inside a puncture needle.The device was simply pulled out and 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 the zap tip of the main coil 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: 12519874
• Report Number: 2134265-2021-11869
• Device Sequence Number: 19948460
• 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): 09/23/2021

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: 02/21/2024
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0027017557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 60