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

Model Number 29460

Device Problems Break (1069); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

It was reported that the distal tip of the microcatheter was fractured.The target lesion was located in the liver.A 135/10 renegade hi-flo kit was selected for use.During unpacking, the microcatheter and annular cannula were flushed.Few seconds after, the microcatheter was removed from the carrier hoop.However, the microcatheter was difficult to remove from the annular cannula and the carrier hoop was re-flushed with saline.It was then noted that the injection head end connection of the microcatheter became fractured.The issue occurred outside the patient.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.

Event Description

It was reported that the distal tip of the microcatheter was fractured.The target lesion was located in the liver.A 135/10 renegade hi-flo kit was selected for use.During unpacking, the microcatheter and annular cannula were flushed.Few seconds after, the microcatheter was removed from the carrier hoop.However, the microcatheter was difficult to remove from the annular cannula and the carrier hoop was re-flushed with saline.It was then noted that the injection head end connection of the microcatheter became fractured.The issue occurred outside the patient.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The hoop was hydrated and the renegade hi flo was removed.The device was inspected for any damage or irregularities.The renegade showed damage in the form of a fracture located 2.5cm from the hub.The inner liner was still attached.It was also noticed there were two kinks, 10cm from the hub and 11cm from the hub.Stretching was seen in several locations on the catheter.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.Device analysis determined the condition of the returned device was consistent with the reported information of a fracture.The hub was not detached; however, fracture and stretching noted.

• Brand Name: RENEGADE HI-FLO KIT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11568747
• MDR Text Key: 242691649
• Report Number: 2134265-2021-03498
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: 08714729280774
• Combination Product (y/n): N
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0025051677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 55