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	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05-nov-2018.It was reported that the catheter was kinked.A 130 direxion hi-flo was selected for use.During preparation, while removing device from packaging, it was noted that the catheter was kinked right after it was removed from hoop.The catheter was never used in the patient.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed a shaft fracture 77cm from the hub.Device evaluated by manufacturer: the device was returned for analysis.The shaft was visually examined.The device showed no kinks.The device showed damage in the form of a fracture located at 77cm from the hub.The device was not completely separated the inner liner was still attached.Per the customers complaint summary, the shaft was fractured during removal from the shipping carrier tube.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: 8103400
• Report Number: 2134265-2018-63232
• Device Sequence Number: 1345823
• Product Code: KRA
• UDI-Device Identifier: 08714729839484
• UDI-Public: 08714729839484
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 07/11/2020
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0022366096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1