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

Catalog Number MF-2.5-18-135-15

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: not exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a mira-flex microcatheter was placed in the liver of a patient with liver cancer 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.

Manufacturer Narrative

Additional information: event.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 there was additional surface damage noted on the catheter surface.Five kinks were noted along the entire length of the catheter.Glue was found on the proximal hub upon inspection.It appears the tubing was separated within the hub due to the glue not holding the tubing inside.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.A device analysis confirmed that there is no evidence suggesting that the device was manufactured out of specification.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.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported on 13aug2018 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
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7818728
• MDR Text Key: 118309353
• Report Number: 1820334-2018-02125
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10827002431154
• UDI-Public: (01)10827002431154(17)201220(10)8495586
• Combination Product (y/n): N
• PMA/PMN Number: K052841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 45