MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number	500-55140
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to ekos for evaluation.The reported fracture was confirmed.The returned microsonic device (msd) was fractured at the distal end of the first proximal transducer.The evaluation found pinch marks in the msd tubing, a dark bump in the msd tubing, and kinks between transducers.Review of the device history record indicate the product was manufactured according to specification and met all acceptance criteria prior to release.The instructions for use contain the following warning: "do not deform or kink the msd during delivery into the iddc.If the msd is kinked at any time, do not attempt to use the msd, as kinking may lead to degraded performance or fracture during use." when ekos field personnel followed up with the facility, they reported the patient was stable and finished therapy.
Event or Problem Description
A 106cm/40cm ekosonic catheter, (b)(4), was used to treat right leg deep vein thrombosis on (b)(6) 2017.The physician successfully placed the infusion catheter (iddc, part of the ekosonic catheter) in the patient and subsequently placed ultrasound core (msd, microsonic device) inside the iddc.After about 10-15 minutes the ekosonic control unit, which controls the ultrasound energy, alarmed with a device over temperature alarm.The physician removed the msd and noticed it was very short.He x-rayed the limb and noticed a section of the msd wire still in the patient.Physician removed ekos catheter and the msd section with no complications.Physician placed a new ekosonic catheter (50 cm) the patient completed therapy.Upon follow-up, the ekos representative added that the physician noticed a small kink in the msd wire when he opened the package.

• 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: 6866742
• Report Number: 3001627457-2017-00027
• Device Sequence Number: 810355
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/28/2017

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 Catalogue Number: 500-55140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 09/14/2017
• 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