MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION FATHOM-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84592
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 17may2022.It was reported that the device was fractured at the hub.The stenosed target lesion was located in the moderately tortuous and moderately calcified left prostate artery.A ngmc/fathom/021/bern/1ro/130 direxion fathom-16 system was selected for use.During the procedure, it was noted that the device was fractured at the proximal hub.The device was removed intact and the procedure was completed with another of the same device.There were no complications reported.However, device investigations revealed that the device was fractured 25.3cm from the hub.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed a fracture located 25.3cm from the hub.The fracture looked to be consistent with a tensile force breaking.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.A fracture was confirmed.

• Brand Name: DIREXION FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14632717
• Report Number: 2134265-2022-06080
• Device Sequence Number: 17621684
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• 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
• Report Date (Section B): 06/08/2022

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: 02/01/2024
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0028789815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White