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

Model Number M001182880

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 fracture occurred.A 135/10 renegade¿ hi-flo¿ was selected for use.During preparation, when withdrawing the catheter completely from the conditioning tube, it was noted that the proximal part near the hub of the renegade¿ was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hi flo micro catheter.The tip, markerband, proximal shaft, and distal shaft was microscopically and tactile inspected.Inspection revealed shaft damage (pinch) located 2.5 cm from the strain relief, and numerous kinks throughout the shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.While the shaft was not fractured as reported, the damage may give the appearance of a fractured shaft when only observed with a naked eye.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 a catheter fracture occurred.A 135/10 renegade hi-flo was selected for use.During preparation, when withdrawing the catheter completely from the conditioning tube, it was noted that the proximal part near the hub of the renegade was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: RENEGADE¿ HI-FLO¿
• 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: 7068562
• MDR Text Key: 93750227
• Report Number: 2134265-2017-12115
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: M001182880
• Device Catalogue Number: 18-288
• Device Lot Number: 20394411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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