MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number N/A

Device Problem Device Handling Problem (3265)

Patient Problems Arrhythmia (1721); Radiation Exposure, Unintended (3164)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

The catheters were not returned for evaluation.Due to the catheters having partially pulled out [user error], the physician decided to terminate the therapy and remove the catheters.The following day the patient was returned to the cath lab for reinsertion of ekos catheters.The patient received a full treatment.The user error [catheters partially pulled out] required medical intervention including additional exposure to x-ray and new catheter placement.The cause of the reported arrhythmias remains unknown.The patient was reported as doing well.The required medical intervention including additional exposure to x-ray and a new catheter placement was due to user error and not a result of a device malfunction.Additional device: catalog # - 500-55118, serial # - (b)(4), expiration date - 06/05/2020, (b)(4), manufacture date - 07/05/2017.

Event Description

On (b)(4) 2017, a helpline call was received from an icu nurse reporting a control unit alarm with an idle screen indicator.The patient came into the er with shortness of breath, went to ir/iv for treatment of a bilateral pe with ij access and then went back to the er before being transported to the icu.At the time of the helpline call, the therapy had been running for 2 hours and 18 minutes.While troubleshooting, the caller stated that the physician was on the way because the patient was having arrhythmias.It was also reported that during transport, the catheters were pulled partially out.Follow up information was received on 29 nov 2017 reporting that they will be redoing the case.The catheters were removed on (b)(6) 2017 and the patient was returned to the cath lab on (b)(6) 2017 for reinsertion of ekos catheters.Additional follow up information was received on 05 dec 2017 reporting that the patient is doing well and that the physician could not determine what caused the arrhythmias.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER
• 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: sandra bausback ; 300 barr harbor dr.; five tower bridge - suite 810; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 7126465
• MDR Text Key: 95176388
• Report Number: 3001627457-2017-00036
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/07/2017
• Device Model Number: N/A
• Device Catalogue Number: 500-55118
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• 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
• Patient Outcome(s): Required Intervention