MAUDE Adverse Event Report: EKOSONIC ENDOVASCULAR CATHETER EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55118
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The msd was returned for evaluation.Visual inspection confirmed that the distal marker band is missing from the tubing.The iddc tubing shows signs of being stretched.The customer had used a merit prelude pro sheath which is not recommended per the ifu.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 bilateral pe case for a total of 14.5 hours.The device was investigated on february 26, 2019 and was found to have the marker band missing.The account was contacted about the missing marker band and reported that the band was in the sheath while the sheath was still in the patient.The customer used a merit prelude pro sheath.The case was completed with no other intervention or injury to the patient.Note that the customer was informed that the style used was against the instructions provided in the ekos ifu.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOSONIC ENDOVASCULAR CATHETER; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 8457463
• Report Number: 3001627457-2019-00012
• Device Sequence Number: 18939801
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

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: 04/30/2021
• Device Model Number: 500-55118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1