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

Model Number	29460
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the outer shaft of the renegade broke.A 135/20 renegade hi-flo kit was selected for use.During preparation, the packaging of the renegade that was pre-loaded with a transend guidewire was flushed but resistance was felt when tried to take out the catheter.Subsequently, the outer shaft of the renegade catheter broke when gently pulled out.The procedure was completed with another of the same device.No complications reported and the patient was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older device was evaluated by the manufacturer, the device was returned for analysis.The tip, inner/outer shaft and hub were microscopically and visually inspected.Inspection revealed a complete separation in the outer shaft located 34cm from the strain relief, and the inner shaft was stretched approximately 3.5cm.Inspection of the remainder of the device, apart from the damage observed revealed no other damage or irregularities.The guide wire that was in the loaded in the shaft with the returned device was tested for functionality.While the guide wire could be advanced in the inner shaft, the wire could not be withdrawn.The inner shaft damage would not allow the wire to be withdrawn.
Event or Problem Description
It was reported that the outer shaft of the renegade broke.A 135/20 renegade hi-flo kit was selected for use.During preparation, the packaging of the renegade that was pre-loaded with a transend guidewire was flushed but resistance was felt when tried to take out the catheter.Subsequently, the outer shaft of the renegade catheter broke when gently pulled out.The procedure was completed with another of the same device.No complications reported and the patient was stable.

• 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: 8798207
• Report Number: 2134265-2019-08315
• Device Sequence Number: 19542742
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 08/23/2019

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: 02/09/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0023475217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1