MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -16; WIRE, GUIDE, CATHETER

Model Number	81720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the guidewire broke and remained inside the patient.The 80% stenosed target lesion was located in the very tortuous and severely calcified liver.A 200x25cm angled fathom -16 guidewire was selected for use in an embolisation procedure to stop bleeding.During procedure, it was noted that the tip of the wire came off.Strong attempt were made to remove the fractured tip without success.However, the rest of the wire was retrieved from the patient's body.The bleeding then seemed to have stopped, thus the procedure was abandoned.No further patient complications were reported and the patient was fine.

• Brand Name: FATHOM -16
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8604884
• Report Number: 2134265-2019-05172
• Device Sequence Number: 2349346
• Product Code: DQX
• UDI-Device Identifier: 08714729961123
• UDI-Public: 08714729961123
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: 81720
• Device Catalogue Number: 81720
• Device Lot Number: 0022763500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/13/2019
• 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: Other