MAUDE Adverse Event Report: COOK IRELAND LTD CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH

Catalog Number CXI-2.6-18-90-P-NS-0

Device Problem Stretched (1601)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol_cap(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that while removing the catheter it became elongated.The target lesion was a chronic total occlusion of the left common iliac artery, approach was ipsilateral retrograde.The device was advanced, with another manufacture's wire guide and it was trapped by the calcified part of the lesion.When the physician attempted to remove catheter, it became elongated/ damaged.The user replaced the device with another one to continue the procedure though; the replacement would not pass through the distal site of the cto, so the procedure ended unsuccessfully with no further treatment.There have been no adverse effects to the patient reported.There have been no adverse effects to the patient reported.

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6992667
• MDR Text Key: 91108579
• Report Number: 1820334-2017-03831
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002500044
• UDI-Public: (01)00827002500044(17)190914(10)7272091
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2017

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 Catalogue Number: CXI-2.6-18-90-P-NS-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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