MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X50CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ultrasonic core (usc) fractured within the patient, and additional intervention was required to retrieve the device fragment.An ekosonic endovascular device, 135x50cm was selected for use in the arterial thrombolysis procedure.During the initial procedure, the infusion catheter (ic) was inserted without issue.When the usc was inserted into the ic, the tip of the usc fractured within the ic.The usc was removed, and the fractured tip was removed using a pair of mosquito forceps.The usc was replaced, and the procedure was completed without further issue.There were no reported patient complications.
Event or Problem Description
It was reported that the ultrasonic core (usc) fractured within the patient, and additional intervention was required to retrieve the device fragment.An ekosonic endovascular device, 135x50cm was selected for use in the arterial thrombolysis procedure.During the initial procedure, the infusion catheter (ic) was inserted without issue.When the usc was inserted into the ic, the tip of the usc fractured within the ic.The usc was removed, and the fractured tip was removed using a pair of mosquito forceps.The usc was replaced, and the procedure was completed without further issue.There were no reported patient complications.
Additional Manufacturer Narrative
Device evaluation: during analysis, the ultrasonic core (usc) was returned in two pieces.The device break was at 90.5 cm from the strain relief.No functional testing was able to take place.The reported event of break was confirmed.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X50CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20267324
• Report Number: 2124215-2024-58688
• Device Sequence Number: 11645515
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K213422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035278422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 113 KG