MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER; CATHETER, CONTINUOUS FLUSH, PRODUCT CODE: KRA

Catalog Number	500-56112
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the device has been requested for further investigation.Our initial analysis based on the lot number provided indicates that the device was manufactured in accordance with our manufacturing procedures and met all quality release criteria.During the follow-up information received by the company on 27-dec-2016 established that the sheath used to place the device was a fast cath by st.Jude medical serial number (b)(4).Product usage with a contra-indicated placement device likely contributed to the issue.The ifu warns users against employing sheaths with rotating hemostasis valves.It states: "do not use an introducer sheath with a rotating hemostasis valve to introduce the ekosonic mach4 endovascular device.Insertion or removal through a rotating hemostasis valve may result in removal of the radiographic marker bands, stretching or other damage to the catheter." initial information provided by the complainant confirmed that the 'patient is well'.Should the risk management release the device for evaluation, a follow up mdr report will be submitted.
Event or Problem Description
Physician called company representative on (b)(6) 2016 to let him know "he had an issue when removing the catheter from the sheath.The ekos catheter got caught within the sheath and the distal marker sheared off.Fortunately, the marker stayed within the sheath and the physician was able to retrieve it." the physician performed a follow-up x-ray to ensure there wasn't any other pieces left after the removal.The patient is well.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: CATHETER, CONTINUOUS FLUSH, PRODUCT CODE: KRA
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 6265474
• Report Number: 3001627457-2017-00001
• Device Sequence Number: 967163
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/24/2016

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: Physician
• Device Expiration Date: 08/21/2019
• Device Catalogue Number: 500-56112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2016
• Initial Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1