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 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 date of event estimated using aware date.Device eval by manufacturer: the ekosonic endovascular device was returned for analysis.Upon initial inspection, the infusion catheter was completely occluded with dried blood, and the coolant and drug ports were unable to be flushed.The infusion catheter was soaked in a warm water bath to loosen the dried blood that was occluding the catheter.After the warm water bath, the coolant lumen was able to be flushed.However, after multiple attempts, the drug port was unable to be flushed.Microscopic visual inspection showed that the drug holes in the infusion catheter were completely occluded with dried blood, which likely led to the inability to flush the drug line.

Event Description

It was reported that there was a drug delivery issue.A 106x12cm ekosonic endovascular device was selected for use in a procedure to treat a pulmonary embolism.During preparation, it was found the tpa part of the catheter was not working.No patient complications were reported.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18388918
• MDR Text Key: 331494480
• Report Number: 2124215-2023-73056
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213422
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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
• Device Lot Number: 8035782131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1