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

Model Number	82865
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that rebleeding was noted.The target lesion was in the kidney vessel.A 4mm/4mm vortx - 18 was used for treatment on (b)(6) 2020 after five other coils were placed.Post procedure, it was found out that the patient was still bleeding thus treated again on (b)(6) 2020.There was nothing abnormal with the coil after it was released successfully.The physician thought the rebleeding was related to the user's operation method as it was very difficult to find the bleeding spot because the kidney artery was brittle and the patient's lesion was difficult to embolize.The patient's condition was stable and there were no further complications reported.It was noted that if the rebleeding could not be controlled, the patient would need to undergo interventional surgery again.

• 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: 10116845
• Report Number: 2134265-2020-07343
• Device Sequence Number: 19294720
• Product Code: KRD
• UDI-Device Identifier: 08714729158882
• UDI-Public: 08714729158882
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0024309129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR