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

Model Number	29420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ro marker detached from the tip of the catheter and travelled down the gastroduodenal artery (gda).The target lesion was located in the mildly tortuous hepatic artery in the liver.A 135/10 renegade hi-flo catheter was selected for use.During the procedure, it was noted that the ro marker of the renegade hi-flo slipped off of the tip of the catheter.The ro marker travelled down the gastroduodenal artery (gda).The catheter was removed intact with the ro marker removed over the wire and the procedure was completed with a different device.No further complications were reported and the patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade hi flo showed damage in the form missing marker band at the distal end.There was stretching and flattening to the entire length of the renegade hi flo.It was also noticed there were kinks, 36.5cm, 57.5cm, 75cm and 122.5cm from the hub.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 detached component.
Event or Problem Description
It was reported that the ro marker detached from the tip of the catheter and travelled down the gastroduodenal artery (gda).The target lesion was located in the mildly tortuous hepatic artery in the liver.A 135/10 renegade hi-flo catheter was selected for use.During the procedure, it was noted that the ro marker of the renegade hi-flo slipped off of the tip of the catheter.The ro marker travelled down the gastroduodenal artery (gda).The catheter was removed intact with the ro marker removed over the wire and the procedure was completed with a different device.No further complications were reported and the patient was fine post procedure.

• Brand Name: RENEGADE HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11797867
• Report Number: 2134265-2021-05574
• Device Sequence Number: 17107395
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: 08714729280637
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2023
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0026457115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention