MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a renegade hi-flo micro-catheter.The shaft showed flattening damage located 123cm and 128.5 from the hub.The device was not completely separated and the inner liner was still connected.The catheter shaft showed flattening at the distal end located 123cm and 128.5 from the hub.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.
Event or Problem Description
Reportable based on device analysis completed on 02-feb-2019.It was reported that the micro catheter could not be removed from the sheath.The target lesion was located at the lungs.A 135/20 renegade hi-flo kit was selected for use.During the procedure, it was noted that the micro catheter could not be taken out from the sheath when unpacking.The carrier hoop was re-flushed with saline.The procedure was completed with another of the same device.There were no patient complications reported.The patient was stable post-procedure.However, device analysis revealed that there was 1 fracture on the shaft located at 26.5cm from the hub.

• Brand Name: RENEGADE HI-FLO KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8366329
• Report Number: 2134265-2019-01637
• Device Sequence Number: 1960231
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0021428633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2019
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 110