MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number	500-55140
Medical Device Problem Codes	Electrical Shorting (2926); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The msd and iddc were returned to ekos and evaluated on 11 sep 2018.The msd was noted to be kinked, with pinch marks in the tubing from 30cm through to the distal end of the strain relief.A small hole (0.2 mm in diameter) identified an area of shorting damage and a kink in the msd at 5 mm from the distal end of the tubing (about 5 mm before the treatment zone starts).This section was dissected and showed evidence of electrical shorting with burn residue and wires exposed through the insulation.A review of the device history record confirmed that the product was manufactured per standard processes and met all acceptance criteria.There have been no other reported complaints from msds of the same lot.The investigation concluded that user handling caused the device damage which resulted in the msd electrical short.The damage could be consistent with a tool being used during advancing the msd into the iddc.The ifu warns the user: do not deform or kink the msd during delivery into the iddc.If the msd is kinked at any time, do not attempt to use the msd, as kinking may lead to degraded performance or fracture during use.The saline coolant came in contact with the burned area in the msd which exits the distal end of the catheter into the patient's blood stream.The electrical short in the msd did not affect the iddc and therefore did not come in contact with the patient's vasculature.The event did not impact the delivery of thrombolytic therapy.The ultrasound was delivered for over 26 hours and it was reported that the treatment continued without ultrasound as standard cdt therapy.No serious injury occurred as a result of this device damage.
Event or Problem Description
It was reported that a 40 cm ekos catheter was used to treat a patient on (b)(6) 2018.The catheter ran for 26 hours and 19 minutes when a temperature alarm occurred.The user rebooted the control unit and the alarm resolved.A few hours later, the user reported another alarm for no zones enabled.Therapy continued using the ekos device as a standard infusion catheter.The patient was reported as "fine" and did not experience any adverse events.Upon investigation of the returned device on 11 sep 2018, device damage was found.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 7910843
• Report Number: 3001627457-2018-00029
• Device Sequence Number: 14020675
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: 04/30/2020
• Device Catalogue Number: 500-55140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1