MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number 500-55106

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

The returned catheter was evaluated on 03 january 2020 and the investigation showed a tool mark on the proximal edge of the treatment zone.Microsonic device (msd) pins all appeared to be in good condition.No other damage was observed on the msd.The msd passed the ring gage test.Blood was observed in the drug lumens at the tip of the catheter.No drug holes were noted outside of the marker bands.A review of the event log showed the therapy on (b)(6) 2019 was performed with a 6cm catheter (b)(4).At 13.3 hours into the therapy an excessive average power alarm occurred due to the catheter wearing out with phase angle at -50 degree.The alarm persisted throughout rest of the case.The catheter disconnected and reconnected many times, and the control unit power cycled more than once.Total of ultrasound delivered was 14.4 hours.The control unit functioned as expected and no issues were observed with the control unit.A review of the manufacturing records indicates that the product was manufactured according to specifications and met all acceptance criteria.The customer reported that the patient was stable.While no patient impact or adverse event was reported, the patient underwent a second procedure to replace the device.

Event Description

On (b)(6) 2019, ekos distributor reported that an error occurred within 24 hours of treatment.Ekos catheter was used for a pulmonary embolism treatment.The alarm could not be resolved after changing to another control unit.A replacement ekosonic catheter was used to complete the treatment.The patient was reported as stable.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway; bothell WA 98011 8809
• Manufacturer Contact: sandara bausback-aballo ; 300 conshohocken state rd,; 300 four falls corporate ctr.; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 9598275
• MDR Text Key: 220808197
• Report Number: 3001627457-2020-00001
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006028
• UDI-Public: 00858593006028
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 500-55106
• Device Catalogue Number: 500-55106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Date Manufacturer Received: 12/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2019
• 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