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

Model Number	82865
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Device evaluated by manufacturer: the main coil was returned for analysis.The coil was returned semi inside of an unknown device.The main coil returned was found kinked and stretched.Microscopic investigations revealed that no damages were found on the zap tip of the main coil.Dimensional inspection revealed that the zap tip, overall dimension of the primary coil matches with specification, however, number of fiber bundles did not match the specification.The fibers bundles were loss due to stretching condition.
Event or Problem Description
Reportable based on device analysis completed on 11mar2021.It was reported that the coil got stuck.A 5mm/5.5 mm vortx-18 embolic was selected for use.During the procedure.The coil was advanced into the catheter.However, it could no longer pass when it reached the distal part of the catheter and was stuck.The device was simply pulled out and the procedure was completed with another of the same device.There no complications reported and the patient was stable.However, device analysis revealed loss of 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: 11575489
• Report Number: 2134265-2021-03659
• Device Sequence Number: 3544359
• 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): 03/26/2021

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: 06/15/2023
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0025717430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 52