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

Model Number	81725
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis.A peel at the polymer jacket section was noted along with a kink at the wire.
Event or Problem Description
Reportable based on device analysis completed on 27-feb 2024.It was reported that guidewire kink occurred.The patient underwent a stent implantation on the superior mesenteric artery.The left groin was punctured, and a 300cm x 10cm fathom periph guidewire was combined with a 4f vertebral artery catheter for the treatment.The guidewire was superselected to the distal end of the artery and a 9x50 carotid stent was delivered to prepare for deployment.During the procedure, the stent was delivered to the abdominal aorta, but could not go further.The guidewire was taken out and found to have been kinked, causing the failure to cross.The device was replaced by another of the same model to successfully deploy the stent and to complete the procedure.There were no complications reported, and patient status was stable.However, returned device analysis revealed that the guidewire was peeled at polymer jacket section and kinked at wire.

• 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: 18943544
• Report Number: 2124215-2024-16660
• Device Sequence Number: 15548864
• Product Code: DQX
• UDI-Device Identifier: 08714729801054
• UDI-Public: 08714729801054
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: 08/28/2025
• Device Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0030047775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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