MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 24CM TZ; CATHETER, CONTINUOUS FLUSH

Device Problems Device Alarm System (1012); Difficult to Flush (1251)

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

Event Date 07/15/2021

Event Type  malfunction  

Event Description

It was reported that an unresolved drug infusion pump alarm occurred.An ekosonic catheter was selected for use for a portal vein occlusion catheter directed thrombolysis procedure.Approximately 30 minutes into the procedure, a down stream occlusion alert occurred to the during infusion pump.The intravenous (iv) line was checked for kinks and closed roller clamps or stopcocks.None were observed.The physician denies aspiration from the drug port or repositioning of the patient.Flushing the iv line with a 1ml and 3 ml syringe was attempted without success.At this time, it was decided to pull the catheter.The patient was brought back the next day for imaging and no further intervention was needed.No patient complications were reported.

• Brand Name: EKOSONIC KIT 106CM 24CM TZ
• 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; two scimed place; maple grove 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12282123
• MDR Text Key: 265209337
• Report Number: 2134265-2021-10028
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1