MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIN ENDOVASCULAR CATHETER

Catalog Number	500-55150
Medical Device Problem Codes	Bent (1059); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter (iddc) and microsonic device (ultrasound wire; msd) was returned to ekos for investigation.A kink was observed on the iddc and multiple pinch marks were observed on the msd.The complainant reported that the treating physician encountered resistance/difficulty when advancing the msd inside iddc.As he/she was not able to complete placement, they removed the iddc and msd and replaced with a similar device (30cm).The new device advanced without any difficulty and they complete the procedure.When ekos field personnel followed up with the facility, they reported that the patient had done very well (verbatim).Since a similar device advanced without any resistance within the same anatomy, a definitive root-cause could not be determined at the time.Review of the manufacturing records indicate that the product was manufactured according to specification and met all acceptance criteria prior to release.
Event or Problem Description
A nurse, supporting the case, reported that the microsonic device (msd; ultrasound wire) did not advance the catheter and the treating physician was unable to place and lock due to resistance.She reported that the treating phyisician opened a similar device (30cm) and placed it easily.

• Brand Name: EKOSONIN ENDOVASCULAR CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek pkway s; bothell WA 98011
• MDR Report Key: 6709515
• Report Number: 3001627457-2017-00022
• Device Sequence Number: 16536658
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/16/2017

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 Expiration Date: 02/27/2020
• Device Catalogue Number: 500-55150
• Device Lot Number: 170322089-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1