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

Model Number M001183020

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a microcatheter break occurred.A 135/10 renegade¿ hi-flo¿ kit was selected for use.During preparation, while the microcatheter was in the carrier hoop, the lumen was flushed with heparinized saline and no leaks were noted.The device was then gently removed from the hoop; however, it was observed that the microcatheter broke into 2 parts.The procedure was completed with another of the same device.There were no patient complications reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Returned product consisted of a renegade hi-flo microcatheter with a.018¿ guidewire.The hub, shaft and tip were microscopically examined and the shaft of the renegade was not fractured or broken.The shaft kinked however 13cm proximal of the tip.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks were attributable to handling of the device.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that a microcatheter break occurred.A 135/10 renegade hi-flo kit was selected for use.During preparation, while the microcatheter was in the carrier hoop, the lumen was flushed with heparinized saline and no leaks were noted.The device was then gently removed from the hoop; however, it was observed that the microcatheter broke into 2 parts.The procedure was completed with another of the same device.There were no patient complications reported and the patient's condition 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: 6827889
• MDR Text Key: 83895496
• Report Number: 2134265-2017-08529
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: M001183020
• Device Catalogue Number: 18-302
• Device Lot Number: 20370757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• 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