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

Catalog Number	CXI-2.6-18-135-ANG
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As originally reported, during a procedure involving a highly calcified, twenty-centimeter chronic total occlusion (cto) of the superficial femoral artery via a contralateral approach, other manufacturers¿ wires were unable to be advanced through a cxi support catheter.The catheter packaging was not damaged, and the device was stored vertically.Access was obtained in the femoral artery, and another manufacturer¿s sheath was used during the procedure.The anatomy was not tortuous, but it was severely calcified.The bifurcation angle was not tight.The user inserted another manufacturer¿s 0.018-inch wire guide into the catheter hub to advance the device to the lesion; however, resistance was encountered and therefore, the 0.018-inch wire was exchanged for another manufacturer¿s 0.014-inch wire.The 0.014-inch wire would only advance halfway through the catheter, near the second marker from the tip.Per the reporter, the tip of the wire guide was altered/shaped prior to insertion into the catheter, during which an inserter was used.Upon encountering resistance, the cxi was removed and exchanged for another manufacturer¿s support catheter.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and evaluation of the device on 24may2024, holes were noted in the catheter shaft.
Additional Manufacturer Narrative
E1: customer name and address = phone: (b)(6).H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Correction: b1, h1, h6 (annex a): upon completion of the investigation, it was determined the "holes" in the catheter shaft are circular pockmark-like damage to the outer layer of the shaft.There are no holes in the catheter, and there was no report from the customer of holes in the catheter.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that this device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 19562056
• Report Number: 1820334-2024-00826
• Device Sequence Number: 20703776
• Product Code: KRA
• UDI-Device Identifier: 00827002231634
• UDI-Public: (01)00827002231634(17)261205(10)15786415
• Combination Product (Y/N): N
• PMA/510(K) Number: K122796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CXI-2.6-18-135-ANG
• Device Lot Number: 15786415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT COMMAND 0.014¿ HYDROPHILIC STRAIGHT.; BOSTON SCI. V18 0.018¿ HYDROPHILIC STRAIGHT.; MEDIKIT/PARENT PLUS 60 6FR.
• Patient Sex: Unknown