MAUDE Adverse Event Report: EKOSONIC ENDOVASCULAR CATHETER EKOSONIC ENDOVASCULAR CATHETER

Model Number	EKOSONIC KIT, 135CM, 40 CM TZ
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter used to complete the therapy was returned for investigation.Visual inspection confirmed that the braided tubing was broken with the internal stiffing wire exposed along an area approximately 10 cm long.All exposed areas of the msd display kinks and abrasions.The msd was doubled over and twisted inside the iddc.The iddc had accordion damage under the strain relief.No evidence of a manufacturing defect was observed.This type of break usually occurs after mechanical damage was done to the shaft, potentially during insertion, and a user applies a force greater than what it is designed for causing external mechanical damage to the msd shaft.Review of the device history record indicated that the product was manufactured according to specification and met all acceptance criteria prior to release.No adverse patient outcome was reported with this event.The physician reported the patient's pao occlusion was completely cleared and the patient was stable.
Event or Problem Description
It was reported that during a peripheral arterial occlusion (pao) case, the doctor used a 40 cm treatment length ekos catheter and a 7 (b)(6) introducer sheath.The bifurcation was reportedly very tortuous.The physician placed the 40 cm ekos with a lot of difficulty.Upon completion of therapy, the pao occlusion was completely cleared and the patient was reportedly stable.The physician reported the core wires were shredded after the device was pulled.There is no patient sequela reported at this time.

• 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: 8441950
• Report Number: 3001627457-2019-00010
• Device Sequence Number: 1253671
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/21/2019

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: 02/28/2020
• Device Model Number: EKOSONIC KIT, 135CM, 40 CM TZ
• Device Catalogue Number: 500-56140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1