MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55112
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a labeling issue a 106x12cm ekosonic endovascular device (ekos) was selected for use in a pulmonary embolism (pe) procedure.When the physician tried to place the ultrasonic core wire in the patient, it was realized that something was wrong.The device was removed from the patient and was measured.The ultrasonic core wire measured 135cm.The device was exchanged and found the second box had the same issue.The device was then exchanged again, and treatment proceeded.
Event or Problem Description
It was reported there was a labeling issue.A 106x12cm ekosonic endovascular device (ekos) was selected for use in a pulmonary embolism (pe) procedure.When the physician tried to place the ultrasonic core wire in the patient, it was realized that something was wrong.The device was removed from the patient and was measured.The ultrasonic core wire measured 135cm.The device was exchanged and found the second box had the same issue.The device was then exchanged again, and treatment proceeded.
Additional Manufacturer Narrative
Device analysis: the ekosonic ultrasonic core (usc) and ekosonic infusion catheter (ic) were returned to boston scientific for analysis.The device was visually inspected for damage and none was noted.The length of the ic measured 107.60 cm, meeting specification.The length of the usc measured 140.40 cm, which does not meet specification for a 106 cm usc.Instead this met specification for a 135cm usc, which confirmed the reported event.The usc was inserted in to the ic and the usc extended 24.30 cm past the distal tip of the ic.The catheter was connected to the control unit and the system information screen confirmed the reported sn as well as listed the device as a 106cm length with a 12 cm treatment zone.The catheter was placed in a water bath with a temperature of 37c and therapy was then started on the control unit.Approximately, two minutes into treatment, a 311 (no zones (groups) enabled) alert occurred.This alarm was dismissed and followed by an e006 (channel cross connection) alert.Therapy was stopped and the system was then shut down to conclude functional testing.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14733238
• Report Number: 2134265-2022-06526
• Device Sequence Number: 12273847
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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: 01/09/2025
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035075233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: REMOVAL # 92887566-FA
• Patient Sequence Number: 1
• Patient Sex: Male