MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-55106

Device Problems Difficult to Flush (1251); Obstruction of Flow (2423)

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

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Lot number: 0011084737.

Event Description

It was reported that a drug occlusion occurred resulting in catheter replacement.An ekosonic kit 106cm 12cm tz was selected for use.During the procedure while infusing in intensive care, there were drug and coolant lumen occlusions.Attempts were made to flush with pressure, but they were unsuccessful.The patient was taken back to the cath lab to exchange ekos catheters.No patient complications were reported, and the patient outcome was fine the next day.

• Brand Name: EKOSONIC KIT 106CM 12CM 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12866578
• MDR Text Key: 281199560
• Report Number: 2134265-2021-14286
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-55106
• Device Catalogue Number: 500-55106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/23/2021
• 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
• Patient Outcome(s): Required Intervention