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

Catalog Number CXI-2.6-18-90-P-NS-ANG

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = k160884.Device evaluated by mfg : 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.

Event Description

It was initially reported that during an unknown procedure in the superficial femoral artery, another manufacturer's guide wire would not advance through a cxi support catheter.An ipsilateral approach was used and the user described feeling resistance as he attempted to advance the guide wire through the device.When the user was unable to advance the guide wire further, he cut the device near the hub.He was still unable to advance the guide wire.The procedure was completed successfully with another similar catheter.Upon receipt of the complaint device and completion of the device failure analysis form on (b)(6) 2019, the investigator found foreign matter within the device.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.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed one used cxi-2.6-18-90-p-ns-ang cxi support catheter separated near the hub into two segments.Biomatter was present on the device.No damage was noted under the strain relief.A section of the catheter measuring 4mm in length is protruding from the strain relief.Wire advance through the proximal (cut off) section.During the functional test a wire guide could not be passed through the hub of the device as a dark brittle material occluded the hub.This brittle material was crushed and put in water, where it began to dissolve.The matter was then tested using the hemident test and the was confirmed to be blood.As this hardened blood blocked the hub if could be a potential cause for the failure mode experienced by the patient.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed one nonconforming event which could contribute to this failure mode.This nonconformance was for inadequate glue on the device, but the affect unit was reworked.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.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 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
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8261009
• MDR Text Key: 133543023
• Report Number: 1820334-2019-00168
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002500020
• UDI-Public: (01)00827002500020(17)210301(10)8636076
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: CXI-2.6-18-90-P-NS-ANG
• Device Lot Number: 8636076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLADIUS 0.014INCH/ASAHI INTECC WIRE GUIDE; GLADIUS 0.014INCH/ASAHI INTECC WIRE GUIDE