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

Model Number 12CM/106CM

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

One catheter was returned for evaluation: catalog number 500-55112; serial no.(b)(4) iddc 12/106cm.The reported complaint that the iddc won't infuse was not confirmed.The iddc evaluation found that all drilled holes are present and drilled holes appear to be not occluded, and disinfection solution flowed from drug holes.Follow up from the ekos rep stated the case was started with a 2nd catheter and the patient was not impacted negatively.The ekosonic mach4 endovascular device instructions for use, page 5., clearly state to prepare the catheters outside of the body by flushing them prior to placement in the patient.According to ekos' internal documentation, this event is not reportable, but complainant expressed his opinion that ekos should report it.

Event Description

The sales rep reported that a physician opened a catheter and it would not flush through the drug lumen.The physician opened a second catheter, flushed it, and placed it in the patient with no difficulty, so the patient was not impacted negatively.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer Contact: susan wray ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 4254891267
• MDR Report Key: 5251648
• MDR Text Key: 32184014
• Report Number: 3001627457-2015-00012
• Device Sequence Number: 1
• Product Code: KRA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 12CM/106CM
• Device Catalogue Number: 500-55112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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