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

Model Number M001195740

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that a catheter tip break occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the moderately tortuous liver.A direxion hi-flo fathom-16 system was selected for use.During the procedure, the direxion microcatheter was placed correctly; however, the physician noticed something in the tip and decided to remove the device from the patient's body.It was then noted that the tip was torn.The procedure was completed a renegade hi-flo device.No patient complications were reported and the patient's status was stable.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7603162
• MDR Text Key: 111157901
• Report Number: 2134265-2018-05268
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K132947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: M001195740
• Device Lot Number: 21743775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR