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

Model Number	84591
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A 130cm direxion hi-flo fathom-16 system was selected for use.During the procedure, it was noted that the catheter had a break along the shaft which caused it to be unusable.There were no complications reported and the patient is doing fine after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was microscopically analyzed for any damage.The devices shaft showed 1 fracture located 52.5cm from the hub.The inner liner showed a kink.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The fractured shaft was confirmed.
Event or Problem Description
It was reported that a shaft break occurred.A 130cm direxion hi-flo fathom-16 system was selected for use.During the procedure, it was noted that the catheter had a break along the shaft which caused it to be unusable.There were no complications reported and the patient is doing fine after the procedure.

• Brand Name: DIREXION HI-FLO 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15193273
• Report Number: 2124215-2022-29080
• Device Sequence Number: 5603414
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 09/13/2022

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: 01/21/2024
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0028721418
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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 Sex: Unknown