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

Model Number	82875
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the coil protruded the catheter's tip during removal.A 5mm/5.5 mm vortx diamond was selected for use.During procedure, it was noted that the coil got stuck in the distal part of the catheter.When catheter and coil were removed, the coil protruded from the catheter's tip.The procedure was completed with a different device.There were no patient complications reported.

• Brand Name: VORTX DIAMOND - 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: 11834876
• Report Number: 2134265-2021-06003
• Device Sequence Number: 19937013
• Product Code: KRD
• UDI-Device Identifier: 08714729324898
• UDI-Public: 08714729324898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/17/2021

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: 04/28/2021
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0022179187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1