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

Model Number 29460

Device Problems Contamination (1120); Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Event Description

It was reported that the device sterility was compromised.A 135/10 renegade hi-flo kit was selected for use.During unpacking, it was noted that the inner package of the device was severely damaged and failed to meet the sterile standard.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device codes corrected from 1120 to 1421 and 3007.Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hi-flo micro-catheter in the original packaging and in the unopened sterile pouch.Examination of the outer packaging showed no damage.The devices pouch was removed from the cardboard box.The sterile pouch was examined for any damage.The pouch was shown to have a tear on the front of the pouch.Inspection of the remainder of the device, except for the observed damage revealed no other damage or irregularities.

Event Description

It was reported that the device sterility was compromised.A 135/10 renegade hi-flo kit was selected for use.During unpacking, it was noted that the inner package of the device was severely damaged and failed to meet the sterile standard.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 8576084
• MDR Text Key: 143988278
• Report Number: 2134265-2019-04806
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0022575944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 65