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

Catalog Number	CXI-2.6-18-150-P-NS-ANG
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 originally reported, the cxi support catheter had a damaged tip during an endoscopic third ventriculostomy procedure.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.Upon return and examination of the complaint device, however, it was noted that there was slight skive damage along the exterior portion of the device.
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.On the initial mdr, a2b & a4b were inadvertently marked 'ni' instead of 'asku' these fields have been updated.Correction g3: on the initial mdr, g3 was inadvertently only marked for 'user facility' when it should have included foreign and health professional as well.This field has been updated.Investigation - evaluation a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, specifications, functional test, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed skive damage.The device failure analysis from pr234004 (original complaint) states ¿one cxi-2.6-18-150-p-ns-ang was returned in a used condition.A kink was noted at end of strain relief.The tip is slightly out of round.Skive damage was noted on the 3rd and 4th black marker bands measuring from the distal tip.Bio matter was present on the catheter.No other damages 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.However, a review of the subassembly lot did reveal two nonconformances.The both were for shaft damage, and both were destroyed prior to finalizing the lot.It should be noted there were no other reported complaints for this lot number.Furthermore, an ifu is provided with the device which states ¿upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause can be traced to manufacturing and quality control deficiency.We will continue to monitor for similar complaints.Measures have been 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.

• 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: 7838044
• Report Number: 1820334-2018-02662
• Device Sequence Number: 1291003
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)191129(10)7474544
• Combination Product (Y/N): N
• PMA/510(K) Number: K072724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 11/29/2019
• Device Catalogue Number: CXI-2.6-18-150-P-NS-ANG
• Device Lot Number: 7474544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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: JUPITER FC 0.014INCH / BOSTON SCIENTIFIC (B)(4)