MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55118
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the returned catheter revealed that the iddc was stretched, there was a kink at 39 cm and the distal marker band was missing.A witness mark was present in the tubing for the missing marker band, indicating that the marker band was originally placed in the correct location during manufacturing.Review of the device history record indicated that the device was manufactured according to specification and met all acceptance criteria prior to release.While it was not confirmed if a rotating hemostasis valve was used, the ifu warns the user that insertion or removal through a rotating hemostasis valve may result in removal of the radiographic marker bands, stretching or other damage to the catheter.There was no impact to the patient; the final outcome was reported as good.
Event or Problem Description
An ekos catheter was used to treat a patient with a bilateral pe on (b)(6) 2018.It was reported that the device would not infuse.During the investigation of the returned ekos catheter 171220091-005 on 18 jul 2018, it was discovered that the distal marker band was missing.

• 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: 7767442
• Report Number: 3001627457-2018-00023
• Device Sequence Number: 2050412
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/18/2018

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: 11/30/2020
• Device Model Number: 500-55118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other