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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It has been alleged that a cxi support catheter was being used during an iliac stenting procedure when it separated.The complainant reports that the patient presented with a highly calcified iliac occlusion, and the catheter would not pass the completely through.Allegedly , as the catheter was partially advanced through the occlusion, the physician began to pull it back but felt resistance.As the physician continued to pull on the catheter, it separated.The remaining section of the catheter was retrieved via snare and the procedure was successfully completed.No other adverse events have been reported regarding this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, dimensional verification, instructions for use (ifu), drawing, quality control data, and visual inspection of the returned device were conducted during the investigation.One used cxi support catheter (cxi-2.6-18-90-p-ns-0) was returned for investigation.The catheter was separated into two sections.Hub and strain relief have no non-conformities.The distal end of the proximal section was frayed.The distal tip of the distal section was flared and damaged.1.0cm of the proximal end of the distal section was twisted.There was one unknown wire guide present, which is completely inserted into the distal section of the catheter.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Per the instructions for use: "precaution - the 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." based on the provided information, inspection of returned product, and the results of our investigation, a definitive root cause cannot be established , although human anatomy likely was a contributing factor.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6755456
• Report Number: 1820334-2017-02202
• Device Sequence Number: 138990
• Product Code: KRA
• UDI-Device Identifier: 00827002500044
• UDI-Public: (01)00827002500044(17)200203(10)7647675
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CXI-2.6-18-90-P-NS-0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 10/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention