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

Model Number 29460

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  malfunction  

Event Description

It was reported that the sterility of the device was compromised.A 135/10 renegade hi-flo kit was selected for use.During preparation, it was noted that the inner sterile bag was damaged after opening the package.The procedure was completed with another of the same device.No patient complications reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hi-flo micro-catheter.The packaging was not returned with the device.The device showed the hub was detached when returned from the customer site.No other damage was noticed on the shaft.Inspection of the remainder of the device, except for the damage observed revealed no other damage or irregularities.

Event Description

It was reported that the sterility of the device was compromised.A 135/10 renegade hi-flo kit was selected for use.During preparation, it was noted that the inner sterile bag was damaged after opening the package.The procedure was completed with another of the same device.No patient complications reported and patient's status was stable.

• 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: 8310167
• MDR Text Key: 135167795
• Report Number: 2134265-2019-00797
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2020
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0022544202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 52