MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X30CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56130
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter had a leak and appears to have been damaged.This ekosonic endovascular device had therapy running on two catheters for this patient.At 13 hours 35 minutes into treatment, there was a leak noted on channel a (distal to the white manifold).The catheter was kinked and had a hole that appeared to have been damaged.The fluid coming out of catheter was bloody, and could not be determined if it was tpa or coolant.All therapy was discontinued on channel a, and the catheter would need to be replaced before resuming therapy.Good faith effort regarding the resolution was requested, however has not been obtained at this time.No patient complications were reported.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X30CM
• Common Device Name: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15283201
• Report Number: 2134265-2022-08494
• Device Sequence Number: 2328849
• Product Code: KRA
• UDI-Device Identifier: 00858593006295
• UDI-Public: 00858593006295
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• 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
• Report Date (Section B): 08/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 500-56130
• Device Catalogue Number: 500-56130
• Device Lot Number: 8035044894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown