MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55140
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The msd was not returned for evaluation.The patient's noncompliance (sitting up in bed) likely caused the kink in the catheter and sheath which contributed to the marker band becoming dislodged during removal.No patient impact or injury was reported in association with this event or the removal of the marker band.Review of the device history record indicated that the product was manufactured according to specification and met all acceptance criteria prior to release.If additional information is received, a follow up report will be submitted.
Event or Problem Description
Ekos was used in a peripheral arterial occlusion case with an antegrade femoral access.It was reported that during removal of the ekos catheter, resistance was noted and under fluoroscopy, the distal marker band was seen in the sheath.It was removed with a snare and there was no patient impact reported.It was reported that the catheter and sheath were kinked due to the patient being noncompliant and sitting up in bed.

• 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: 7544069
• Report Number: 3001627457-2018-00019
• Device Sequence Number: 2029365
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: 04/30/2020
• Device Model Number: 500-55140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1