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

Catalog Number	CXI-4.0-35-90-P-NS-0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No code available ((b)(4)) for adverse event - aborted procedure.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
During a left leg angioplasty procedure, it was reported, a crosscath support catheter was advanced over a tight angle/steep bifurcation in the patient's anatomy.No scarring of the access site or calcification of the vasculature was reported.A hiwire hydrophilic wire guide was activated with heparinized saline and advanced through the catheter but perforated through the catheter at the point of the steep bifurcation.A kink was noted in the crosscath support catheter.These two devices were removed from the patient and a cxi support catheter was then used and kinked at the bifurcation as well.This device was removed and the procedure was aborted.Per the complainant the probable cause for device failures was patient anatomy.Per the complainant, the procedure will not be rescheduled.No patient adverse effects have been reported.This report captures the aborted procedure.Please reference also 1820334-2018-02607 which captures sharp edges on the crosscath support catheter.
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 complaint history, device history record, documentation, drawing, instructions for use(ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that there was biomatter on the winged hub.The catheter shaft under the strain relief was checked for damage, however none was visible.The outer diameter was 12cm, and the overall length from the distal end to the strain relief was 90.0cm.All marker bands were present.No kinks or other signs of damage were noted.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 be noted there were no other reported complaints for this lot number.Furthermore, an ifu is provided with the device, which states ¿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.This catheter should only be used by physicians qualified to perform percutaneous vascular interventions.¿ moreover, a review of the 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 traced to the device but may lie with the patient¿s condition as a steep bifurcation 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: 7889956
• Report Number: 1820334-2018-02689
• Device Sequence Number: 2365877
• Product Code: KRA
• UDI-Device Identifier: 00827002525467
• UDI-Public: (01)00827002525467(17)210409(10)8759068
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072724
• 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): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2021
• Device Catalogue Number: CXI-4.0-35-90-P-NS-0
• Device Lot Number: 8759068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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: PREVIOUSLY STATED; PREVIOUSLY STATED
• Outcome Attributed to Adverse Event: Other