MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; CATHETER, CONTINUOUS FLUSH

Model Number 500-56112

Device Problem Unsealed Device Packaging (1444)

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

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

Premarket 510(k) # k183361; k182324.

Event Description

It was reported that the device packaging seal was broken, and sterility was compromised.An ekosonic endovascular device, 135x12cm was selected for the pulmonary embolism procedure.During device preparation, it was discovered that the outer box was damaged, as though the corner had been crushed.Additionally, the seal of the device packaging was torn.The device sterility was questioned, and the device was discarded.The procedure was completed using a non-bsc mechanical thrombectomy device.There were no reported adverse consequences to the patient.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): EKOS CORP INC; 11911 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16294354
• MDR Text Key: 308757208
• Report Number: 2124215-2023-03673
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: 500-56112
• Device Catalogue Number: 500-56112
• Device Lot Number: 0010173696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1