MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORK LIMITED RENEGADE HI-FLO KIT; CATHETER, CONTINUOUS FLUSH

Model Number	29460
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 06nov2018.It was reported that the micro catheter couldn't be taken out from the protector after flushing a 135/20 renegade hi-flo kit was selected for use during a tace procedure for a patient with liver cancer.During preparation, it was reported that the micro catheter couldn't be taken out from the protector after flushing.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition after the procedure was stable.However, analysis revealed that the shaft was fractured 50.2cm from the hub.Device evaluated by mfr: the device was returned for evaluation.Returned product consisted of a renegade hi-flo micro-catheter.The hub, shaft and tip were microscopically examined.This device showed damage consisting of 1 fracture on the shaft.The fracture was located 50.2cm from the hub.The shaft was not completely separated the inner liner was still connected.The stretching and the fracture that was noticed on the device are consistent with the device being removed from the shipping tube without being completely hydrated with saline.The distal end of the shaft showed multiple kinks from the tip to proximally 16cm.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.

• Brand Name: RENEGADE HI-FLO KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORK LIMITED; ballybrit business park; galway 92729 ; EI 92729
• MDR Report Key: 8075437
• Report Number: 2134265-2018-62952
• Device Sequence Number: 13883516
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: 06/11/2020
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0022368430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1