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

Catalog Number	MF-2.5-18-135-15
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: not exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a mira-flex microcatheter was placed in the liver of a patient with cirrhosis during a tace procedure.As the microcatheter was inserted into the target site to deliver the contrast agent, the tip of the microcatheter became detached.The physician replaced the catheter with a like device and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, specifications, as well as a dimensional verification and visual inspection of the returned device was conducted during the investigation.One used mira-flex catheter with the hub detached was returned for evaluation.Biological matter was present on the device and no additional surface damage was noted.Glue was present on the proximal hub, but it appears the tubing was separated within the hub due to the glue not holding the tubing inside.A supplier investigation was conducted on the returned product and found that none of the products failed manufacturing specifications put in place for hub separation.Additionally, a document based investigation evaluation was performed.The instructions for use (ifu) warns of exceeding maximum dynamic or static pressures, as this may result in catheter damage.The user is also instructed to inspect the device prior to use to ensure that no damage has occurred.A 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.Based on the information provided, the examination of the returned product and the results of our investigation, it is possible that the cause could be related to user technique.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported on (b)(6) 2018 that concomitant products included mf-2.5-18-135-15, tpmg-16c-180-tc45-flx12 and terumo's rf*dg35008m.The patient's anatomy did not have significant tortuosity or calcification.

• 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: 7818335
• Report Number: 1820334-2018-02491
• Device Sequence Number: 11084471
• Product Code: KRA
• UDI-Device Identifier: 10827002431154
• UDI-Public: (01)10827002431154(17)210102(10)8584933
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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 Expiration Date: 01/02/2021
• Device Catalogue Number: MF-2.5-18-135-15
• Device Lot Number: 8584933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 42