MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH

Model Number 500-55112

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Device media analysis: an ekosonic endovascular device was returned for analysis with the cord cut.The ultrasonic core (usc) from this kit was not returned.During decontamination, the device was observed to have significant leakage from the luer ports to both the drug line and coolant line.Visual inspection revealed a kink in the catheter at 45cm from the manifold.The device was able to be flushed through the manifold luer with no apparent clogging.Microscopic visual inspection of the exterior of the catheter confirmed that both the drug and coolant luer ports were significantly cracked.Potential clogs were also noted in some of the drug holes.Although potential clogs were noted in some of the drug holes, due to the significant cracking of the luer ports, the drug line was unable to be properly flushed and the reported event of clogging could not be confirmed.

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that the catheter was clogged following an overnight placement.An ekosonic endovascular device, 106x12cm was selected for use.The ekos catheter was placed in the patient and infusion began immediately.The patient was transferred to the icu for treatment overnight.In the morning, it was observed that the catheter was clogged.It was undetermined whether the clog was within the drug line or the coolant line.No pump alerts were reported.The catheter was removed from the patient and treatment was concluded at that time.There were no reported adverse consequences to the patient.However, device analysis revealed the drug line was clogged.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16016178
• MDR Text Key: 306265875
• Report Number: 2124215-2022-53779
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1