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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The patient was being treated for liver metastases and underwent bland embolization.The non-stenosed target lesion was located in the severely tortuous and non-calcified vessel.A180x35cm fathom -16 guidewire was advanced; however, during the procedure, the guidewire tip broke off.The tip was held together by an internal thread and was pulled back into the microcatheter and was successfully retrieved.The procedure was completed with another guidewire.There were no complications reported and the patient status was fine.
Additional Manufacturer Narrative
Device evaluated by mf.R: the device was returned for the analysis, and it is possible to see that the guidewire was bent and stretched at the distal section, polymer jacket was peeled.
Event or Problem Description
It was reported that tip detachment occurred.The patient was being treated for liver metastases and underwent bland embolization.The non-stenosed target lesion was located in the severely tortuous and non-calcified vessel.A180x35cm fathom -16 guidewire was advanced; however, during the procedure, the guidewire tip broke off.The tip was held together by an internal thread and was pulled back into the microcatheter and was successfully retrieved.The procedure was completed with another guidewire.There were no complications reported and the patient status was fine.

• Brand Name: FATHOM -16
• 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: 18672465
• Report Number: 2124215-2024-04749
• Device Sequence Number: 17678073
• Product Code: DQX
• UDI-Device Identifier: 08714729762560
• UDI-Public: 08714729762560
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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 Model Number: 81720
• Device Catalogue Number: 81720
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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