MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55118
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the iddc showed both distal and proximal marker bands indentations were present on the tubing but the marker bands themselves were not.The stiffening wire was bent at 8.3 cm and wavy wires were seen throughout the tubing.There was a kink at the distal tip of the strain relief.Tool marks were observed on the msd shaft at 8.7 cm and 17.6 cm.Blistering was observed over the transducer elements.During follow-up, the customer reported that one iddc was difficult to remove and extended and stretched during removal.The missing marker bands were not reported by the user.Review of the device history record confirmed that the product was manufactured per standard processes and met all acceptance criteria.There have been no other reported complaints from msds of the same lot.No patient harm was reported.Per the account there was "nothing left in the patient" because they could have seen the marker band on fluoroscopy.It is unknown if the marker bands were dislodged inside the patient or not.The ifu warns the user to not advance if resistance is met.Excessive force against resistance may result in damage to the device or vasculature.User error was not confirmed but could not be ruled out as a contributing factor to the marker band dislodgement.There were two devices with serial numbers 180801037-001 and 190614023-005 used during the case.This mdr is for the second device with serial number 190614023-005.Mdr for the first device was submitted under mfr # 3001627457-2019-00038 (201901889).
Event or Problem Description
On (b)(6) 2019, 6 hours and 31 minutes into therapy, account called with an alternating white c red thermometer/blue thermometer alarm.Ekos catheter was placed to treat a bilateral pulmonary embolism (pe).Ultrasound was paused.After troubleshooting, the staff reconnected and started ultrasound and yellow light flashing.The connector interface cable (cic) was on top of the blankets, dressing was clean and intact, and iv tubing/roller clamps/stopcocks were all open.Patient was stable and on a ventilator.During follow-up, the customer stated when trying to pull out ultrasound wire it was stuck and stretched.On (b)(6), two catheters were returned without the marker bands.Upon follow-up, the customer informed that "the patient did well" and there was "nothing left in the patient" because they would have seen the marker band on fluoroscopy.One intelligent drug delivery catheter (iddc) was difficult to remove and extended and stretched during removal.The account stated that they did not think that hemostasis valve was used.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 9281020
• Report Number: 3001627457-2019-00039
• Device Sequence Number: 18935070
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• 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): 10/11/2019

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: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 500-55118
• Device Catalogue Number: 500-55118
• Device Lot Number: 190614023-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1