MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -14; WIRE, GUIDE, CATHETER

Model Number	81725
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an accumulation of coating at the tip occurred.A 200cmx10cm fathom -14 guidewire was selected for use.During preparation, when the wire was pulled from the hoop, there was almost what felt like a small ball accumulating on the very distal tip of the wire.The wire was immediately removed from the table and the procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that an accumulation of coating at the tip occurred.A 200cmx10cm fathom -14 guidewire was selected for use.During preparation, when the wire was pulled from the hoop, there was almost what felt like a small ball accumulating on the very distal tip of the wire.The wire was immediately removed from the table and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.No damages were detected on the device during visual inspection.During functional inspection, the device was soaked in saline solution in order to activate the coating at distal section.When the coating was activated, no issues were identified in the distal tip coating.No other issues were identified during the product analysis.

• Brand Name: FATHOM -14
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18174844
• Report Number: 2124215-2023-61899
• Device Sequence Number: 7687170
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: 08714729801023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 07/19/2026
• Device Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0032057510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown