MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER; CATHETER, CONTINUOUS FLUSH, PRODUCT CODE: KRA

Catalog Number 500-56130

Device Problems Kinked (1339); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device condition prevented qa from performing detailed bench top evaluation.The complainant left the luer fitting from the packaging coil (the product is secured with a luer on the packaging coil to withstand shipping) and attempted to place the msd.Though this may not have directly contributed to the reported difficulty, it would have prevented proper msd placement and locking.Minor pinch marks were observed on the msd.The microsonic device, partially in-situ in iddc, was damaged near proximal end.When ekos followed up, the complainant reported that they completed the procedure with a similar device and the patient was "ok".Review of the manufacturing records indicate that the product was manufactured according to the specifications and met all acceptance criteria prior to release.The instructions for use (ifu) states that "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".A definitive root-cause could not be determined at this time.

Event Description

Ekos field rep received an email complaint report from the physician's assistant about this incidence.The complaint indicated that the treating physician was unable to advance the microsonic device (msd) in ilio femoral artery and subsequently encountered difficulty in removing both catheter and msd for replacement.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH, PRODUCT CODE: KRA
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek pkway s; bothell WA 98052
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek pkway s; bothell WA 98011
• Manufacturer Contact: mani shanmugham ; 11911 north creek pkway s; bothell, WA 98011 ; 4254891279
• MDR Report Key: 6704561
• MDR Text Key: 79925777
• Report Number: 3001627457-2017-00021
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006295
• UDI-Public: 00858593006295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/16/2019
• Device Catalogue Number: 500-56130
• Device Lot Number: 160809087-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1