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

Model Number	81720
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating of the guidewire was coming off.A fathom 16.016, 180x35cm, peripheral guidewire was selected for use in a transarterial chemoembolization (tace) procedure in the liver.While retracting the wire back through the introducer needle, it was reported that the coating of the fathom was coming off.It was confirmed that no coating and/or fragments were left inside the patient and the procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the coating of the guidewire was coming off.A fathom 16.016, 180x35cm, peripheral guidewire was selected for use in a transarterial chemoembolization (tace) procedure in the liver.While retracting the wire back through the introducer needle, it was reported that the coating of the fathom was coming off.It was confirmed that no coating and/or fragments were left inside the patient and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
H6: device codes was previously reported as a04 material integrity problem and has been corrected to a0501 detachment of device or device component.

• 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: 11985198
• Report Number: 2134265-2021-07513
• Device Sequence Number: 3831730
• Product Code: DQX
• UDI-Device Identifier: 08714729762560
• UDI-Public: 08714729762560
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 01/12/2024
• Device Model Number: 81720
• Device Catalogue Number: 81720
• Device Lot Number: 0026622270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 08/31/2021
• Patient Sequence Number: 1