MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VORTX - 35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83095
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil peeled.A vortx - 35 coil was selected for a hepatic embolization procedure.It was noted that the coil peeled in the guide.The procedure was completed with a 4mm vortx coil and a 5mm 2d helical coil.There were no patient complications reported and the patient's status was stable.

• Brand Name: VORTX - 35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10025741
• Report Number: 2134265-2020-05997
• Device Sequence Number: 2937902
• Product Code: KRD
• UDI-Device Identifier: 08714729237273
• UDI-Public: 08714729237273
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: 12/12/2021
• Device Model Number: 83095
• Device Catalogue Number: 83095
• Device Lot Number: 0023077733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1