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

Catalog Number	CXI-2.3-14-150-ANG
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported, during a right leg up-and-over procedure on a (b)(6) male using a cxi support catheter, a portion from the tip of the device separated.Access was via the left common femoral artery, and the patient's anatomy was said not to have been tortuous, but moderately calcified.The complaint device was able to be advanced and then removed to insert a balloon device.It was reported that there was no resistance felt during the insertion or the removal of the device.While the device was on the back table and before it was grabbed to be used again in the procedure, it was then observed that the black distal tip had separated on the back table.Nothing had detached while it was in the patient.Another of the same device was used to successfully complete the procedure.Photo's of the device were requested; however, they are not available at this time.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.
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.Correction: investigation evaluation.A review of the complaint history, device history record, documentation, manufactures instructions, and quality control of the device was conducted during the investigation.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 not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.However, during a review of the subassembly lot revealed two nonconformances, one for shaft damage, and the other for tubing.Although these nonconformances may be related to the reported failure mode, all affected units were scrapped and not replaced.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions, drawings, and quality control procedures was conducted, and no gaps were discovered.Moreover, a tensile test of the tip to the shaft bond was performed on the.035 cxi using a computer-controlled electromechanical testing system.A total of 29 units were tested.The acceptance criterion of the study was that the maximum load measured for each test specimen shall be greater than 10 n.All 29 test specimens were greater than 10 n, therefore, the acceptance criterion was met.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be traced to the device, but instead lies with patient condition as moderate calcification was reported.We will continue our monitoring of similar complaints and have 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.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.

• 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: 8037119
• Report Number: 1820334-2018-03218
• Device Sequence Number: 1434979
• Product Code: KRA
• UDI-Device Identifier: 00827002183766
• UDI-Public: (01)00827002183766(17)210926(10)9190192
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2021
• Device Catalogue Number: CXI-2.3-14-150-ANG
• Device Lot Number: 9190192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR