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

Model Number	G52547
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: k160884.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, a (b)(6) male with a medical history of lower limb arterial occlusion was undergoing stent implantation of the femoral artery.According to the initial reporter, the tip of the cxi support catheter fell off while advancing it along the wire guide.The complaint device was withdrawn and replaced to complete the procedure.Reportedly, there was no problem noted prior to advancing the cxi support catheter.It flushed without difficulty.The patient did not experience any adverse effects as a result of this event.A section of the device did not remain inside the patient's anatomy.The patient did not require any additional procedures as a result of this event.
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.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one cxi in a used and damaged condition was returned for investigation.The device was in two pieces.The first piece comprised of the hub and strain relief.The second piece was comprised of approximately 91.7cm of catheter tubing.At the proximal end of the catheter tubing, there was an approximately 2mm long damaged twisted portion.The distal tip of the catheter appeared intact, with no other surface damage.Trace biomatter was present on the tubing and the hub.We noted no twisting on the catheter tubing aside from the portion of the proximal end.During the functional test, the strain relief was removed from the hub.Upon removal, a portion of the catheter tubing was noted inside the hub.This likely indicated shaft separation as opposed to hub separation.A.035 wire guide was passed through the lumen of the catheter shaft from the proximal end.A portion of the wire was passed through with difficult and was not able to pass through to the end.Based on this observation, there was likely biomatter obstructing the lumen.Dimensional verification confirmed that the device was manufactured within specification.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 no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions, drawing, and quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which provides the necessary warnings, precautions, and instructions.Based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to device component failure due to the user and unintended use error.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.
Additional Manufacturer Narrative
B5: additional information was received from the cook representative on 25jan2019, which provided the patient's anatomy did not have any scarring, calcification, or tortuosity.Torque was not applied to the complaint device while advancing it over the wire guide.No other devices, other than the wire guide, were being used at the time of the event.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 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.
Event or Problem Description
Please see h10 for additional information received 01/25/2019.

• 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: 8261055
• Report Number: 1820334-2019-00113
• Device Sequence Number: 2081671
• Product Code: KRA
• UDI-Device Identifier: 00827002525474
• UDI-Public: (01)00827002525474(17)200327(10)7779039
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2019

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: 03/27/2020
• Device Model Number: G52547
• Device Catalogue Number: CXI-4.0-35-90-P-NS-DAV
• Device Lot Number: 7779039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/25/2019; 03/19/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 01/28/2019; 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED WIRE GUIDE; UNSPECIFIED WIRE GUIDE
• Patient Age: 70 YR
• Patient Weight: 72