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

Model Number	N/A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
It was reported that a cxi support catheter was used to treat the lesion in bk region.The catheter got kinked during the procedure and became impossible to use.Another manufacturer's device was used instead without problems.There were no reported adverse effects to the patient as a result of this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of device history record, documentation, drawing, ifu, manufacturing instructions, specifications, quality control, and trends was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.Another device from the same lot number was returned to the manufacturer - no non-conformances were noted to the hub, strain relief, or catheter.The similar device is free of kinks, is not bent, and is free of debris.A review of the non-conformance data revealed no non-conformances for the complaint lot number 7258449.A search for the same lot number revealed no other complaints.Based on the complaint event, it is reasonable to suggest that the damage occurring during the procedure was due to an eventual patient condition or to an eventual higher pressure applied on the device.However, a definitive root cause could not be determined.We will notify the appropriate personnel and 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: 6663968
• Report Number: 1820334-2017-01494
• Device Sequence Number: 71909
• Product Code: KRA
• UDI-Device Identifier: 00827002500013
• UDI-Public: (01)00827002500013(17)190908(10)7258449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CXI-2.6-18-150-P-NS-0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1