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

Model Number 500-55112

Device Problems Device Alarm System (1012); Difficult to Flush (1251); Obstruction of Flow (2423)

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

Event Date 08/18/2021

Event Type  malfunction  

Event Description

It was reported that there was a downstream occlusion alarm on the drug infusion line.An ekosonic kit 106cm 12cm tz was selected for use in a bilateral pulmonary embolism.During the procedure at a therapy run time of 13 hours 45 minutes, a downstream occlusion alarm occurred on the drug infusion line.The helpline was called, and troubleshooting was performed.No kinks in the lines were observed, the patient had not been repositioned, the site had not been redressed, and the head of the bed had not been raised.A lower rate was attempted, but the control unit 4.0 still alarmed.Back pressure in the tubing was relieved, but the alarm continued.The pressure settings on the alaris pump were checked, and it was at 525 mmhg.A forward flush was attempted with a 3cc syringe, but it was unsuccessful.Coolant was kept running.Ultrasound was turned off, and channel a was disabled without tpa infusing.The physician determined that the patient received adequate lytic delivery.No patient complications were reported; the patient was fine.

• 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: 12436920
• MDR Text Key: 270292882
• Report Number: 2134265-2021-11216
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2024
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035017210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1