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

Model Number M001183020

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned stuck inside a 5fr guide catheter (.038 id).The hub, tip and a partial portion of the shaft was examined for any damage.The device showed multiple kinks and bends on the portion that was visible.Also 12cm of the tip was exposed from the distal end of the guiding catheter.The shaft was broken but not completely separated and the inner liner was intact.The tip looked to be stretched and kinked approximately 5 to 6cm from the tip.The device was x-rayed but there was no indication of internal damage that would cause a sticking issue.The guiding catheter that was returned with the device showed some bends.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.Dfu states, it is recommended that a continuous saline flush be maintained between the guiding catheter and the microcatheter and between the microcatheter and the guidewire during the procedure.The returned device that was stuck inside of the guiding catheter showed no evidence that this taking place.(b)(4).

Event Description

Reportable based on device analysis completed on 06-jun-2018.It was reported that the tip became deformed and was difficult to withdraw.The target lesion was located in the common hepatic artery.A 135/10 renegade¿ hi-flo¿ kit was selected for use.During introduction, the catheter was advanced into the target lesion and medicine was injected; subsequently, x-ray showed that the distal end of the microcatheter had an obvious inflation.Upon removal, the renegade catheter got stuck inside the angiography catheter and couldn't be retrieved.The procedure was completed with another of the same device.No patient complications were reported and patient's was stable.However, device analysis revealed that the shaft was broken.It was further reported that the device became fractured when the device was removed from the angiographic catheter.

• 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: 7635468
• MDR Text Key: 112312709
• Report Number: 2134265-2018-05638
• 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
• Report Date: 06/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2019
• Device Model Number: M001183020
• Device Catalogue Number: 18-302
• Device Lot Number: 0021583638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR