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

Model Number M001183020

Device Problems Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the tip of the catheter was broken.A 135/10 renegade¿ hi-flo¿ kit was selected for use.During preparation, it was noted that the tip of device was found broken when the package was opened.The procedure was completed with another of the same device.No complications were reported and the patients' status was stable.

Manufacturer Narrative

The renegade device was not returned, what was returned was a guidewire introducer which is included in the renegade packaging.The guidewire introducer was checked for damage, it was noticed that the plastic luer lock on the guidewire introducer was broken.Since the renegade device was not returned, an investigation on the actual device could not be done.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the tip of the catheter was broken.A 135/10 renegade¿ hi-flo¿ kit was selected for use.During preparation, it was noted that the tip of device was found broken when the package was opened.The procedure was completed with another of the same device.No complications were reported and the patients' status was stable.

• Brand Name: RENEGADE¿ HI-FLO¿ KIT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6573292
• MDR Text Key: 75421184
• Report Number: 2134265-2017-04758
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K000177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: M001183020
• Device Catalogue Number: 18-302
• Device Lot Number: 0019744823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1