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 Code	Foreign Body In Patient (2687)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire was fractured and remained inside the patient.The non-stenosed target lesion was located in the tortuous and non-calcified vessel in the abdomen.A 200x25cm angled fathom -16 guidewire was selected for use in an endoleak procedure.During the procedure, the device was used to navigate the vessel.After multiple passes, it was noted that the guidewire fractured at the ileolumbus branch.As the fracture occurred in a vessel that was planned to be embolized, the fractured portion was left inside the vessel.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the returned guidewire had the distal tip detached and bent.No other issue or anomalies were identified.The distal tip section was not returned.Microscope inspection revealed that the returned guidewire had the distal tip detached.Dimensional inspection revealed that the components were within specification.The customer provided pictures related to the complaint and media inspection was performed.X-ray screen images were provided where it is possible to observe the device, however, there is no clear evidence that the device was broken from the photos attached.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the guidewire was fractured and remained inside the patient.The non-stenosed target lesion was located in the tortuous and non-calcified vessel in the abdomen.A 200x25cm angled fathom -16 guidewire was selected for use in an endoleak procedure.During the procedure, the device was used to navigate the vessel.After multiple passes, it was noted that the guidewire fractured at the ileolumbus branch.As the fracture occurred in a vessel that was planned to be embolized, the fractured portion was left inside the vessel.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the returned guidewire had the distal tip detached and bent.No other issue or anomalies were identified.The distal tip section was not returned.Microscope inspection revealed that the returned guidewire had the distal tip detached.Dimensional inspection revealed the components were within specification except the overall length which was only 76.26 out of 78.74" +/-.25.The customer provided pictures related to the complaint and media inspection was performed.X-ray screen images were provided where it is possible to observe the device, however, there is no clear evidence that the device was broken from the photos attached.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the guidewire was fractured and remained inside the patient.The non-stenosed target lesion was located in the tortuous and non-calcified vessel in the abdomen.A 200x25cm angled fathom -16 guidewire was selected for use in an endoleak procedure.During the procedure, the device was used to navigate the vessel.After multiple passes, it was noted that the guidewire fractured at the ileolumbus branch.As the fracture occurred in a vessel that was planned to be embolized, the fractured portion was left inside the vessel.The procedure was completed with another of same device.No 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14229294
• Report Number: 2134265-2022-04709
• Device Sequence Number: 4407597
• Product Code: DQX
• UDI-Device Identifier: 08714729961123
• UDI-Public: 08714729961123
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/17/2022

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 Expiration Date: 11/25/2024
• Device Model Number: 81720
• Device Catalogue Number: 81720
• Device Lot Number: 0028456351
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/12/2022; 05/31/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/01/2022; 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 68 KG