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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

It was reported that a catheter break occurred.The target lesion was located in the liver.A 135/10 renegade hi-flo kit was selected for use.During unpacking, the catheter and carrier tube were flushed.However, the microcatheter was difficult to remove from the carrier tube and the middle of the microcatheter became fractured.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 a catheter break occurred.The target lesion was located in the liver.A 135/10 renegade hi-flo kit was selected for use.During unpacking, the catheter and carrier tube were flushed.However, the microcatheter was difficult to remove from the carrier tube and the middle of the microcatheter became fractured.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 renegade showed damage in the form multiple bends and kinks.There was a stretched and fractured area located 47cm from the hub.The device was not completely separated, the inner liner was still attached.The device showed no other damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 11171803
• MDR Text Key: 226858510
• Report Number: 2134265-2021-00294
• 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: 02/04/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0024925595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60