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

Model Number M001182880

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

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the shaft was broken.A 135/10 renegade¿ hi-flo¿ was selected for use.During preparation, outside the patient's body, the carrier tube was hydrated before removing the catheter.However, it was noted that the shaft was broken upon removal from carrier tube.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The tip, markerband, proximal shaft, and distal shaft were microscopically and tactilely inspected.Inspection revealed a separation in the outer shaft at 42.5cm from the strain relief, and the inner braiding stretched for 5 cm between the outer shaft separations.The outer shaft of the device was slightly tacky to the touch.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that the shaft was broken.A 135/10 renegade hi-flo was selected for use.During preparation, outside the patient's body, the carrier tube was hydrated before removing the catheter.However, it was noted that the shaft was broken upon removal from carrier tube.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: RENEGADE¿ HI-FLO¿
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6975779
• MDR Text Key: 90890782
• Report Number: 2134265-2017-10484
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001182880
• Device Catalogue Number: 18-288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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