MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ekosonic msd was returned in two pieces with the iddc.The device evaluation revealed pinch marks throughout the msd tubing; the msd fracture was noted at the proximal end of group 5 and the shaft to treatment zone junction.Visual inspection of the iddc noted a kink in the tubing and the stiffening wire at 9.4 cm.The ifu warns the user if the product is damaged or found to be unusable in any way, please retain the product and notify ekos corporation immediately.User error was not confirmed, but could not be ruled out as a cause or contributing factor to the msd fracture.
Event or Problem Description
It was reported that a 50 cm ekos catheter was used to treat a patient with a unilateral arterial occlusion on (b)(6) 2018.The catheter ran one hour and 39 minutes.When it was pulled out, it was discovered the msd was fractured inside the iddc.The 50cm catheter was replaced with a 30cm that ran for 20 hours and it was reported that the patient did fine.The patient was not harmed as a result of the fractured msd.Upon investigation of the returned device, the reported complaint was confirmed by device damage.

• 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: 7492335
• Report Number: 3001627457-2018-00015
• Device Sequence Number: 19160936
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: Physician
• Device Expiration Date: 08/23/2020
• Device Model Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1