MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 135CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-56112

Device Problem Defective Device (2588)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported that thrombus occurred.An ekosonic catheter was selected for use to treat a thrombus located in the superficial femoral artery (sfa).The underlying medical condition of the patient was acute thrombus.Heparin was given at 12mg/hr and lytic at 1 mg/hr over the course of 24 hours.During treatment of the thrombus with the ekosonic catheter, the clot was not cleared up, and it increased in severity while the catheter was in place.The physician observed that the pulse was lost in the foot.The increase in thrombus was attributed to a catheter malfunction by the physician.The procedure was then completed the following day with a cdt catheter.There were no further patient complications.

• Brand Name: EKOSONIC KIT 135CM 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13727002
• MDR Text Key: 287112360
• Report Number: 2134265-2022-02414
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500-56112
• Device Catalogue Number: 500-56112
• Device Lot Number: 8035048652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female