MAUDE Adverse Event Report: COOK INC MIRA-FLEX MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during trans-catheter arterial chemoembolization the connection of catheter was found separated when the user injected the medicine.The catheter was replaced with a new device to finish the 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.".
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, documentation, drawing, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.The mira-flex microcatheter was returned for evaluation.The material of the length of the device appeared elongated.Separation of the proximal fitting from the catheter was confirmed.Visual examination confirmed that no material was found present between strain relief and hub fitting.A document based investigation evaluation was also performed.A review of the device history record data revealed no non-conformances which could contribute to this failure mode.There were no other reported complaints for this lot number.Based on the available information and results of the investigation it is possible that the separation may have been caused by excessive force during handling, however, a definitive root cause could not be conclusively determined.Measures have been initiated to address this issue.The appropriate personnel have been notified and monitoring for similar complaints will continue.

• Brand Name: MIRA-FLEX MICROCATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6089632
• Report Number: 1820334-2016-01251
• Device Sequence Number: 1123983
• Product Code: KRA
• UDI-Device Identifier: 10827002431154
• UDI-Public: (01)10827002431154(17)190207(10)6532906
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K052841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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: MF-2.5-18-135-15
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 58