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

Model Number G18376

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant products= 300cm hydro st, high flex ansel sheath.Occupation = unknown.Pma/510(k) number = k122796.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure, debris was found coming from a cxi support catheter.Access was obtained in the groin to cross a total occlusion in the anterior tibial.While using the device with a wire guide and sheath, the user reported that the wire would torque; however, resistance was felt in the catheter after a "couple of minutes".The wire was exchanged, but resistance was still encountered.The complaint device was then flushed and green particles were observed coming from the catheter.A new catheter and wire were then used to cross the occlusion and complete the procedure.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

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6: ec methods code desc.- 5: communication/interviews (4111).Description of event: as reported, during an unknown procedure, debris was found coming from a cxi support catheter.Access was obtained in the groin to cross a total occlusion in the anterior tibial.While using the device with a wire guide and sheath, the user reported that the wire would torque; however, resistance was felt in the catheter after a "couple of minutes".The wire was exchanged, but resistance was still encountered.The complaint device was then flushed and green particles were observed coming from the catheter.A new catheter and wire were then used to cross the occlusion and complete the procedure.Investigation ¿ evaluation a visual inspection and functional test 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, manufacturing instructions, and quality control data.The complainant returned one cxi to cook for investigation.There was no visible damage or biomatter on the returned device.A 0.014" wire was advanced through the cxi hub.Upon entering the catheter shaft there was a crunching sound.Slight resistance was felt, but the wire was able to be passed through.When the wire exited the catheter, a clear liquid exited the distal tip.No other substance exited the catheter and no debris was found on the wire.The catheter flushed without difficulty and some unknown green particles flushed out.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) provided with this device caution, "this 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.¿ the ifu further states, "upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded a definitive cause for this event could not be determined.A capa was initiated to further investigate and address this failure mode.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 Description

No new patient or event information to report.

• 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: 9595779
• MDR Text Key: 177374572
• Report Number: 1820334-2020-00134
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002183766
• UDI-Public: (01)00827002183766(17)221119(10)10159744
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: G18376
• Device Catalogue Number: CXI-2.3-14-150-ANG
• Device Lot Number: 10159744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1