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

Model Number	G50003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
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.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.
Event or Problem Description
As reported, during angioplasty, a a cxi support catheter separated.The device was flushed from the hub, removed from the holder, then advanced over another manufacturer's wire guide and through another manufacturer's sheath.Upon reaching the distal superficial femoral artery, the lesion was totally occluded.The user felt resistance to continued advancement and removed the device, noticing that the hub had detached.A new device of the same type was used to complete the procedure successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.The patient did not experience any adverse effects.Upon inspection of the returned device, the shaft of the device was separated within the hub.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during angioplasty, a a cxi support catheter separated.The device was flushed from the hub, removed from the holder, then advanced over another manufacturer's wire guide and through another manufacturer's sheath.Upon reaching the distal superficial femoral artery, the lesion was totally occluded.The user felt resistance to continued advancement and removed the device, noticing that the hub had detached.A new device of the same type was used to complete the procedure successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.The patient did not experience any adverse effects.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One used cxi-2.6-18-150-p-ns-ang was returned for investigation.The device was received with the hub and strain relief separated.The hub was separated from the catheter.Part of the catheter remained in the hub.There was twisting of the shaft material (approximately 6mm) from the point of separation.The wire braid was exposed from the distal end of the hub (where it separated from the catheter shaft).A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿the catheter should not be advanced through and area of resistance unless the source of the resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ based on the available information, cook has concluded that the patient¿s anatomy was responsible for the device failure.The sfa lesion was noted to be totally occluded, and the catheter twisting damage near the separation point provides evidence of the resistance encountered before the separation failure.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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.

• 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: 14940056
• Report Number: 1820334-2022-01164
• Device Sequence Number: 12310953
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)250125(10)14495730
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 01/25/2025
• Device Model Number: G50003
• Device Catalogue Number: CXI-2.6-18-150-P-NS-ANG
• Device Lot Number: 14495730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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: 6FR X 45CM FORTRESS SHEATH; ASAHI 0.018" WIRE GUIDE
• Patient Sex: Male