MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK DIREXION TRANSEND-14 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number M001195810

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a direxion micro-catheter with the ¿y¿ adapter.The shaft was microscopically examined.The device showed 2 fractures on the nickel shaft.The 1st fracture was located 2mm from the hub.The 2nd fracture was located 37.5cm from the hub.No other damage was noticed on the shaft.The device was not completely separated the inner liner was intact.The ¿y¿ connector was returned with the device and applied to the manifold.A syringe with fluid was attached to the ¿y¿ connector and pressure was applied to the syringe.The fluid exited the tip of the device and no fluid was leaking from the hub or the ¿y¿ connector.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on device analysis completed on 24-jul-2018.It was reported that leak in the hub occurred.Vascular access was obtained via the right femoral artery.A direxion transend-14 system was selected for use.During procedure, a leakage from the y connector was noted.The procedure was completed with this device.No patient complications were reported.However, device analysis revealed a fracture on the nickel shaft 37.5cm from the hub.

• Brand Name: DIREXION TRANSEND-14 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: 7786018
• MDR Text Key: 117271175
• Report Number: 2134265-2018-07283
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2019
• Device Model Number: M001195810
• Device Lot Number: 21429290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2017
• 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