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

Model Number	81725
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device fracture occurred, requiring snare for removal.The target lesion was located in the vessel of the liver.A 200cm x 10cm fathom -14 guidewire was selected for transhepatic arterial chemoembolization (tac).However, during the procedure, it was found that part of the guidewire was fractured inside the patient.The fractured part was removed with a snare, and the procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection was performed, and it was observed that the guidewire was bent and detached at distal tip.Based on analysis of the returned product, the reported allegation can be confirmed, since the detached tip was found during the visual test.
Event or Problem Description
It was reported that device fracture occurred, requiring snare for removal.The target lesion was located in the vessel of the liver.A 200cm x 10cm fathom -14 guidewire was selected for transhepatic arterial chemoembolization (tac).However, during the procedure, it was found that part of the guidewire was fractured inside the patient.The fractured part was removed with a snare, and the procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.

• 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: 19618740
• Report Number: 2124215-2024-38446
• Device Sequence Number: 6955005
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: 08714729801030
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 0033338995
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2024
• 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: 70 YR
• Patient Sex: Unknown