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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a (b)(6) old male with liver cancer underwent a transarterial chemoembolization (tace) procedure.The user injected domestic iodipin and the tip of the microcatheter was found detached.The device was replaced with a new device to finish the procedure.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation.The returned device was evaluated and found that the hub and catheter were separated with no other visible damage on the device.A review of the device history record was performed and found no non-conformances associated with this lot.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.It is possible that the separation could have been caused by excessive force or pressures during handling.Measures have been initiated to address this issue.Per the quality engineering risk assessment no further action is required.

• 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: 6004324
• Report Number: 1820334-2016-01061
• Device Sequence Number: 1397754
• Product Code: KRA
• UDI-Device Identifier: 10827002431154
• UDI-Public: (01)10827002431154(17)180804(10)NS6382458
• 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): 07/31/2017

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: 09/08/2016
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 DA