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

Model Number	81725
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fracture occurred requiring additional intervention.Vascular access was obtained via femoral artery.The target lesion was located in the carotid artery procedure.A 200 cm x 10 cm fathom -14 guidewire was selected for use.The patient was sedated with local anesthesia.During the procedure, a balloon was delivered along with the guidewire to the lesion.However, it was noted that the guidewire suddenly fractured partially.The fracture guidewire was completely removed from the patient by a thrombectomy stent, and the procedure was ended.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that guidewire fracture occurred requiring additional intervention.Vascular access was obtained via femoral artery.The target lesion was located in the carotid artery procedure.A 200 cm x 10 cm fathom -14 guidewire was selected for use.The patient was sedated with local anesthesia.During the procedure, a balloon was delivered along with the guidewire to the lesion.However, it was noted that the guidewire suddenly fractured partially.The fracture guidewire was completely removed from the patient by a thrombectomy stent, and the procedure was ended.No complications were reported, and the patient was stable post procedure.It was further reported that fractured part of the guide wire was separated from the rest of the guidewire and the tip is inside the blood vessel, and the snare cannot hook the guidewire tip, and the procedure was cancelled.
Event or Problem Description
It was reported that guidewire fracture occurred requiring additional intervention.Vascular access was obtained via femoral artery.The target lesion was located in the carotid artery procedure.A 200 cm x 10 cm fathom -14 guidewire was selected for use.The patient was sedated with local anesthesia.During the procedure, a balloon was delivered along with the guidewire to the lesion.However, it was noted that the guidewire suddenly fractured partially.The fracture guidewire was completely removed from the patient by a thrombectomy stent, and the procedure was ended.No complications were reported, and the patient was stable post procedure.It was further reported that fractured part of the guide wire was separated from the rest of the guidewire and the tip is inside the blood vessel, and the snare cannot hook the guidewire tip, and the procedure was cancelled.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection shows only a section of the distal tip was returned, and it was observed that it was bent and detached.Media inspection showed the distal tip fractured and bent both outside and inside the patient.Based on the evidence, the reported allegations of guidewire fractured was confirmed.

• 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: 19604443
• Report Number: 2124215-2024-37172
• Device Sequence Number: 7318128
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: 08714729801023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

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 Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0033007691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 08/30/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/22/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 65 KG