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

Model Number	80619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: no date reported, so the first day of the month of the aware date was selected.
Event or Problem Description
It was reported that a separation of the shaft occurred.A direxion hi-flo catheter was selected for a patient procedure involving the patient's liver.During the procedure, inside the patient, the shaft of the catheter became fractured.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: no date reported, so the first day of the month of the aware date was selected.Device evaluated by mfr: returned product consisted of a direxion micro-catheter in multiple pieces.The device showed damage in the form of 5 fractures.The fracture was located at the hub, 3.5 cm from the hub, 8cm from the hub, 11.5cm from the hub and 67.5cm from the hub.The device was completely separated.The fractures looked consistent with a bending and tensile force breaking.All the fractured pieces were measured to verify everything was returned.The finished direxion length for this model is 130cm, the returned device pieces showed that all components of the shaft were returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.A fracture were confirmed.
Event or Problem Description
It was reported that a separation of the shaft occurred.A direxion hi-flo catheter was selected for a patient procedure involving the patient's liver.During the procedure, inside the patient, the shaft of the catheter became fractured.No patient complications were reported.

• Brand Name: DIREXION HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8541312
• Report Number: 2134265-2019-04087
• Device Sequence Number: 2431169
• Product Code: KRA
• UDI-Device Identifier: 08714729839514
• UDI-Public: 08714729839514
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: 12/17/2020
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0023098616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1