MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORK LIMITED 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	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the catheter became fractured.A direxion hi-flo microcatheter was selected for use.During procedure, it was noted that the catheter was not responding to the torque and was then removed from the patient's body.However, it was noted that the proximal shaft of the catheter was fractured and had a shredded appearance upon removal.The entire catheter was removed successfully and nothing was left inside the patient's body.The procedure was completed with a different device.No patient complications were reported and patient's status was stable.Device evaluated by mfr: the device was returned for analysis.The returned product consisted of a direxion micro-catheter.The shaft was microscopically inspected.The device showed damage in the form of a fractured shaft in 1 location at 31.8cm from the hub.The device was not completely separated as the inner liner was still intact.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 CORK LIMITED; cork business technology park; model farm road; cork ; EI
• MDR Report Key: 7802885
• Report Number: 2134265-2018-60346
• Device Sequence Number: 1290782
• Product Code: KRA
• UDI-Device Identifier: 08714729839491
• UDI-Public: 08714729839491
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/21/2018

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: 05/24/2020
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0022167898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1