MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -16; WIRE, GUIDE, CATHETER

Model Number	81720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the fathom wire snapped, fell off in the artery and was removed by snaring.The non-stenosed target lesion was located in the moderately tortuous and non-calcified femoral artery.A 200x25cm fathom -16 was selected for use.During the procedure, the fathom wire snapped while navigating inside the artery.As the physician pulled back on wire, it snapped and fell off in the femoral artery.The piece was snared out of the patient and the procedure was completed with another of the same device.No further patient complications were reported.
Additional Manufacturer Narrative
H6 - patient code: corrected to no clinical signs, symptoms or conditions device evaluated by mfr: the guidewire and the torque device were returned for evaluation.It was observed the core wire was exposed, revealing the guidewire was detached at 9.7 cm from distal tip, confirming the reported event.
Event or Problem Description
It was reported that the fathom wire snapped, fell of the artery and was removed by snaring.The non stenosed target lesion was located in the moderately tortuous and non calcified femoral artery.A 200x25cm fathom -16 was selected for use.During the procedure, the fathom wire snapped while navigating inside the artery.As the physician pulled back on wire, it snapped and fell off in the femoral artery.The piece was snared out of the patient and the procedure was completed with another of the same device.No further patient complications were reported.
Event or Problem Description
It was reported that the fathom wire snapped, fell of the artery and was removed by snaring.The non stenosed target lesion was located in the moderately tortuous and non calcified femoral artery.A 200x25cm fathom -16 was selected for use.During the procedure, the fathom wire snapped while navigating inside the artery.As the physician pulled back on wire, it snapped and fell off in the femoral artery.The piece was snared out of the patient and the procedure was completed with another of the same device.No further patient complications were reported.

• Brand Name: FATHOM -16
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15941165
• Report Number: 2124215-2022-50554
• Device Sequence Number: 6394473
• Product Code: DQX
• UDI-Device Identifier: 08714729961116
• UDI-Public: 08714729961116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2023

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: 09/21/2025
• Device Model Number: 81720
• Device Catalogue Number: 81720
• Device Lot Number: 0030202507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 01/19/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/16/2022; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown