MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number	500-56140
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was returned to ekos for evaluation on 9/27/17.Visual inspection of the returned catheter revealed crazing and cracking in the manifold lure.A colored fluid was injected through the lure lock and leaking was observed from the lure confirming the reported issue.Our review of manufacturing records indicates that product was manufactured according to our specification and met all release criteria.During our investigation we found the three-way stop cocks to be very tightly attached to the lures.We advised the customer that care should be taken when connecting the lure locks to securely connect the lures while avoiding overtighting.We are filling this mdr in response to the user facility's medwatch report #(b)(4) that we received from the (b)(4) on 9/11/2017.According to the user facility's medwatch, a new device was replaced in the patient and care of the patient was not compromised.The original plan to use ekos overnight was resumed.There was no report from the user of an adverse patient impact.
Event or Problem Description
A 135cm/40cm ekosonic catheter, s/n (b)(4), was used to treat a patient 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.It was reported to ekos that fluid was leaking from the catheter.They described the manifold section (where the msd and iv fluids meet) of catheter as the source of the leak.The nurse notified the physician the catheter would need to be replaced.

• 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: 6930207
• Report Number: 3001627457-2017-00030
• Device Sequence Number: 16307383
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/08/2017

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: 02/28/2020
• Device Catalogue Number: 500-56140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 95