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

Model Number M001195740

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The shaft was microscopically examined.The device showed a separation of most of the shaft.The only portion that was returned was approximately 33.5cm long from the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/ procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 16-feb- 2017.It was reported that leak in the hub occurred.The target location was located in the liver.A direxion hi-flo fathom-16 system was selected for use.During the procedure, it was noted that there was leakage of chemotherapeutic agent from the hub of the device.The procedure was completed with another of the same procedure.No patient complications reported.However, device analysis revealed a separation of most of the shaft.

• 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: 6391019
• MDR Text Key: 69515584
• Report Number: 2134265-2017-01648
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: M001195740
• Device Lot Number: 0019643402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2016
• 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