MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number	500-56140
Medical Device Problem Codes	Fracture (1260); Electrical Shorting (2926); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The msd was returned to ekos and evaluated on 06 aug 2018.Evaluation of the returned msd revealed evidence of damage.The msd was noted to be kinked, twisted and flattened throughout.The msd shaft was broken in 2 pieces and frayed at 27 cm from the distal strain relief with burned and exposed rf wires.The exposed wires showed evidence of electrical shorting.The iddc was not returned for evaluation.A review of the device history record for the msd confirmed that the product was manufactured per standard processes and met all acceptance criteria.The damage on the msd 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.The event did not impact the delivery of thrombolytic therapy.The control unit event log recorded that ultrasound was delivered for a total of 7 hours and 17 minutes 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 with a peripheral arterial occlusion on (b)(6) 2018.The catheter ran for 7 hours and 17 minutes when an 'all msd failure' alarm occurred.The treatment was continued without ultrasound as a standard cdt therapy without any patient impact.Upon investigation of the returned device on 06 aug 2018, device damage was confirmed.

• 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: 7837517
• Report Number: 3001627457-2018-00026
• Device Sequence Number: 19417152
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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: 08/31/2020
• Device Catalogue Number: 500-56140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1