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

Model Number	80619
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis done on 25sep2018.It was reported that the shaft kink occurred.A 027/155 direxion hi-flo was selected for use to treat a lesion located in the liver, vascular access was gained via the right groin and it was noted that the microcatheter kinked during the procedure.The catheter was removed and an additional direxion microcatheter was used to complete the procedure.Device evaluated by mfr: the shaft was microscopically examined.The device showed damage in the form of a fractured shaft in 1 location.The shaft was fractured 62.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7945316
• Report Number: 2134265-2018-61707
• Device Sequence Number: 770085
• Product Code: KRA
• UDI-Device Identifier: 08714729839521
• UDI-Public: 08714729839521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 07/26/2020
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0022433868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR