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

Model Number	29420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: the patient is in his 60's.
Event or Problem Description
It was reported that shaft break occurred.A 115/10 renegade hi-flo catheter-infusion was selected for use.During the procedure, while taking out the catheter out of the sterile packaging and was attempting to flush the catheter and remove it from the packaging hoop, the catheter came apart in multiple pieces.The catheter was not fully removed from the hoop.There were no damaged found to the shipping box and internal packaged.The procedure was completed with a different device and the patient was not harmed.
Event or Problem Description
It was reported that shaft break occurred.A 115/10 renegade hi-flo catheter-infusion was selected for use.During the procedure, while taking out the catheter out of the strerile packaging and was attempting to flush the catheter and remove it from the packaging hoop, the catheter came apart in multiple pieces.The catheter was not fully removed from the hoop.There were no damaged found to the shipping box and internal packaged.The procedure was completed with a different device and the patient was not harmed.
Additional Manufacturer Narrative
A2 - age at time of event: the patient is in his 60's.Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The device was partially in the shipping tube when returned.The device showed damage in the form of stretching and fractures located 3.5cm and 66.5cm from the hub.The shipping hoop was hydrated, and the device was removed.The device was not completely separated, the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 12450626
• Report Number: 2134265-2021-11054
• Device Sequence Number: 19716951
• Product Code: KRA
• UDI-Device Identifier: 08714729280613
• UDI-Public: 08714729280613
• Combination Product (Y/N): N
• 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): 10/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0024873424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1