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

Model Number	N/A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a recanalization procedure on the (b)(6) year old female patient, the doctor was attempting to cross a calcified vessel, using the cook cxi catheter.However, the catheter kinked, dissecting the vessel.The patient required an additional procedure due to this event as a stent was placed due to the vessel dissection.Additional information provided on 12 may 2016: the surgeon was pushing the catheter tip against a very hard calcified lesion and could not advance the catheter.The surgeon then did a run through the sheath and discovered that the vessel had dissected distally to the lesion itself, even though he had not yet managed to cross the lesion.He then tried to re-advance the wire through the catheter and he discovered the kink in the shaft.The surgeon feels the catheter may have kinked below the level of his wire as he was pushing on the lesion.No part of the device remained inside the patient.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, device history record, and instructions for use (ifu) of the product was conducted.A review of device history records found the catheter from the complaint lot 6829645 to be one of (b)(4) devices manufactured.No non conformances or re-works were logged by quality control against this lot.The device is supplied with an ifu which lists flow rates, intended use, warnings, precautions, potential adverse events and directions for use.Specifically, it states, ¿the catheter should not be advanced into a vessel having a reference vessel diameter smaller than the catheter outer diameter¿the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ vessel dissection is listed as a potential adverse event.The surgeon stated that he was pushing the catheter tip against a very hard calcified lesion and he could not advance the catheter.This is not recommended per the ifu.Visual inspection of the returned device showed kinks along the most distal 5 cm of the catheter.The damage displayed was indicative that cxi device was not placed completely over the wire guide.In these cases, the physician should always lead with the wire guide in order to reduce the likely hood of the cxi catheter kinking.Excess force and user technique contributed to this failure mode.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.No further risk reduction activities are required.
Event or Problem Description
During a recanalization procedure on the (b)(6) female patient, the doctor was attempting to cross a calcified vessel, using the cook cxi catheter.However, the catheter kinked, dissecting the vessel.The patient required an additional procedure due to this event as a stent was placed due to the vessel dissection.Additional information provided on 12 may 2016: the surgeon was pushing the catheter tip against a very hard calcified lesion and could not advance the catheter.The surgeon then did a run through the sheath and discovered that the vessel had dissected distally to the lesion itself, even though he had not yet managed to cross the lesion.He then tried to re-advance the wire through the catheter and he discovered the kink in the shaft.The surgeon feels the catheter may have kinked below the level of his wire as he was pushing on the lesion.No part of the device remained inside the patient.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5686282
• Report Number: 1820334-2016-00359
• Device Sequence Number: 213448
• Product Code: KRA
• UDI-Device Identifier: 00827002525474
• UDI-Public: (01)00827002525474(17)190321(10)6829645
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CXI-4.0-35-90-P-NS-DAV
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2016
• Supplement Report FDA Received Date: 10/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR