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

Model Number M001183030

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

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2017

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 a catheter break occurred.A 135/20 renegade¿ hi-flo¿ kit was selected for use.During unpacking, it was noted that the catheter was broken.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Other relevant history, device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: returned product consisted of a renegade hi-flo micro-catheter.The hub, shaft and tip were microscopically examined.The device was broken/damaged in 2 places.The 1st place was 2cm from the hub.The 2nd place was approximately 2cm from the hub to 14.5cm distally.The liner was also detached on this device approximately 44cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).

Event Description

It was reported that a catheter break occurred.A 135/20 renegade¿ hi-flo¿ kit was selected for use.During unpacking, it was noted that the catheter was broken.The procedure was completed with a different device.No patient complications were reported and the patient's 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: 7060980
• MDR Text Key: 93232200
• Report Number: 2134265-2017-11831
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: M001183030
• Device Catalogue Number: 18-303
• Device Lot Number: 0019498451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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