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

Model Number M001184500

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Age at te time of event: 18 years or older.(b)(4).

Event Description

It was reported that the catheter was broken.A renegade¿ hi-flo¿ fathom¿ system was selected for use.During preparation, the hoop was flushed with saline.However, when the catheter system was removed from the hoop; it was noted that the catheter became frayed.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The hub, shaft and tip were microscopically examined, which revealed the shaft was broken in one place, 10cm from the hub.The shaft was not completely separated the inner liner was still connected.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 investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that the catheter was broken.A renegade hi-flo fathom system was selected for use.During preparation, the hoop was flushed with saline.However, when the catheter system was removed from the hoop; it was noted that the catheter became frayed.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: RENEGADE¿ HI-FLO¿ FATHOM¿ 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: 7574938
• MDR Text Key: 110278599
• Report Number: 2134265-2018-05295
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K100892
• 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,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Model Number: M001184500
• Device Lot Number: 21260576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• 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