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

Catalog Number	CXI-4.0-35-90-P-NS-DAV
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that prior to patient contact, the cxi support catheter (4.0 fr gauge) tip came off when attempting to load the catheter on a 0.35 inch diameter wire guide.The physician switched to a 0.18 inch diameter wire guide system, and utilized a cxi-2.6-18-90-ang (2.6 fr gauge) catheter instead.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.
Additional Manufacturer Narrative
Additional information: narrative: it was later clarified by the customer in a response to a request for additional information that the cxi support catheter tip came off inside of the patient's anatomy, and was required to be retrieved with a snare.Corrected information: additional information received; adverse event/ serious injury occurred as the tip of the catheter was required to be removed from the patient's anatomy.Based on additional information received, the event did not occur prior to a procedure as the cxi support catheter came into contact with the patient.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, device history record, drawing, instructions for use (ifu), manufacturing instructions, 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 the catheter shaft was separated at the proximal end of the third marker band.The separation site was not clean; it appeared frayed on the proximal side, and badly burnt/melted on the distal side.The lumen of the catheter was closed by the melted marker band material.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.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• 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: 7035582
• Report Number: 1820334-2017-03908
• Device Sequence Number: 1901319
• Product Code: KRA
• UDI-Device Identifier: 00827002525474
• UDI-Public: (01)00827002525474(17)200605(10)7965335
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K072724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2018

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 Catalogue Number: CXI-4.0-35-90-P-NS-DAV
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 03/19/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 11/27/2017; 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention