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

Model Number	G56552
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: clinical specialist.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 an atherectomy and angioplasty of the tibial artery, the hub of a cxi support catheter separated from the device upon forceful removal from the patient.Access was obtained in both the right femoral and left pedal arteries.Chronic total occlusions were reported in the tibioperoneal trunk, anterior tibial, and posterior tibial arteries.The device was reportedly pulled forcefully from the left pedal access site, over an unknown, kinked wire guide.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during an atherectomy and angioplasty of the tibial artery, the hub of a cxi support catheter separated from the device upon forceful removal from the patient.Access was obtained in both the right femoral and left pedal arteries.Chronic total occlusions were reported in the tibioperoneal trunk, anterior tibial, and posterior tibial arteries.The device was reportedly pulled forcefully from the left pedal access site, over an unknown, kinked wire guide.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, interview of personnel, manufacturing instructions, and quality control data.The complainant returned one used cxi catheter to cook for investigation.Physical examination of the returned device showed that the entire device was returned curled.The catheter was separated at the strain relief.The catheter shaft length in its current state measured 153.3cm.Further inspection found the catheter shaft was pulled completely out of the hub resulting in hub separation.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.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use: ¿the cxi support catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.¿ 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: ¿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.Cook has concluded that the patient¿s anatomy and procedure contributed to this incident.As reported, the lesion was reported to be a cto of tp trunk/at/pt.Additionally, it was reported that the user was pulling the catheter out of body over wire forcefully and the wire kinked which hindered the transition over wire.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.
Event or Problem Description
No new patient or event information to report.

• 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: 10795613
• Report Number: 1820334-2020-02027
• Device Sequence Number: 1137877
• Product Code: KRA
• UDI-Device Identifier: 00827002565524
• UDI-Public: (01)00827002565524(17)221002(10)10056370
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 10/02/2022
• Device Model Number: G56552
• Device Catalogue Number: CXI-2.6-18-150-0
• Device Lot Number: 10056370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 108