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

Model Number	G52544
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a vasodilation and using a cxi support catheter, it was noted that the cxi tip was frayed.There was no damaged noted to the package prior to the procedure.Access was gained from the right femoral artery, and the target site was the right external iliac artery.A contralateral approach was used.The reported cxi was used as a support for a wire guide.Calcification was rather severe, and the user could not advance the cxi through.Tortuosity was not noted.When they removed it, it was noted that the tip was frayed.Therefore, another manufacturers device was used to complete the procedure.No adverse effects to the patient were reported.
Event or Problem Description
There is no new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: h6 (annex code g).Description of event: as reported, during a vasodilation and using a cxi support catheter, it was noted that the cxi tip was frayed.There was no damaged noted to the package prior to the procedure.Access was gained from the right femoral artery, and the target site was the right external iliac artery.A contralateral approach was used.The reported cxi was used as a support for a wire guide.Calcification was rather severe, and the user could not advance the cxi through.Tortuosity was not noted.When they removed it, it was noted that the tip was frayed.Therefore, another manufacturers device was used to complete the procedure.No adverse effects to the patient were reported.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions ¿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.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complainant reported that during the procedure they encountered a severely calcified lesion that caused resistance, and cook believes that this contributed this incident.Therefore, cook concluded that patient anatomy was the cause of the reported failure.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: b1, h1.B1, h1: upon review of the file, it has been determined that this event is not reportable.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 has been received.

• 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: 12697556
• Report Number: 1820334-2021-02386
• Device Sequence Number: 14628553
• Product Code: KRA
• UDI-Device Identifier: 00827002525443
• UDI-Public: (01)00827002525443(17)230717(10)13312633
• Combination Product (Y/N): N
• PMA/510(K) Number: K160884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2022

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 Expiration Date: 07/17/2023
• Device Model Number: G52544
• Device Catalogue Number: CXI-4.0-35-150-P-NS-0
• Device Lot Number: 13312633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 02/03/2022; 03/08/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 02/08/2022; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• 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: 35 RADIFOCUS/TERUMO; PARENT6F 50/MEDIKIT; 35 RADIFOCUS/TERUMO; PARENT6F 50/MEDIKIT
• Patient Age: 60 YR
• Patient Sex: Male