MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number	500-55150
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Electrical Shorting (2926)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation revealed a kink in the iddc tubing within 2 mm of the mds fracture.The msd was found to be fractured at 64.6 cm with pinch marks at 43.5 cm.The fracture zone exhibited regions of excess heating indicative of a short within the device.Evidence of kinking and tensile failures were noted in the msd.It was noted that the msd did not actually separate into two pieces until the end of the case when the msd catheter was withdrawn from the patient.The catheter system being kinked while in use, either during insertion or interactions with a guide sheath, and/or patient movement could have resulted in wire damage within the msd causing the performance noted in the log file and the bent inner wires within the msd fracture region.When the msd was being removed, the tensile force cause the remaining wires within the fracture region that had not broken to break in a tensile manner.No serious injury occurred, it was reported that the patient did great.There were no indications of manufacturing defects.Review of the msd device history record confirmed that the product was manufactured per standard processes and met all acceptance criteria.The ifu warns the user to not advance if resistance is met without first determining the cause of resistance under fluoroscopy and taking any necessary remedial action.Excessive force against resistance may result in damage to the device or vasculature.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 following the end of a patient treatment, upon removal of the catheter, the distal end of the catheter was bent at a right angle.As soon as the user touched the msd, the distal end fell off.Upon investigation of the returned device, the reported complaint 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: 7298766
• Report Number: 3001627457-2018-00006
• Device Sequence Number: 957421
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/30/2018

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: 09/25/2020
• Device Catalogue Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1