MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X40CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55140
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the patient was brought back to the catheterization lab for catheter replacement.A 106x40cm ekosonic catheter was selected for use in a 4 hour left arterial unilateral case.Tissue plasminogen activator (tpa) was given at 25ml/hr and coolant was at 35ml/hr.Difficulty placing the catheter in the left leg occurred.An all groups disabled alarm displayed.The nurse was in the intensive care unit (icu) with the patient and could not get the control unit (cu) to run.Troubleshooting was performed; however, the alarm persisted.The patient was brought back to the catheterization lab for catheter replacement.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the returned device was inspected for any damage or irregularities.The infusion catheter (ic) was returned with blood in the coolant lines to the luer.The ultrasonic core (usc) device showed damage in the form of a severe kink at the luer barb and at the distal tip.The usc had advancement tool markings/ kinks throughout the device.The ic showed some damage in the form of wavy wires throughout the device.The device ran in a warm water bath to attempt to replicate the sites reported alarm.About 15mins into treatment the device began alarming with an e311 alarm.Disconnecting and reconnecting the device resolved the issue but the device alarmed about 30sec later with the same alarm.The device continued this type of alarming until the device was shut down.Analysis of the in-house event log showed that the deice usc phase was too high, so the groups shut off.This is likely due to wire damage of the usc.
Event or Problem Description
It was reported that the patient was brought back to the catheterization lab for catheter replacement.A 106x40cm ekosonic catheter was selected for use in a 4 hour left arterial unilateral case.Tissue plasminogen activator (tpa) was given at 25ml/hr and coolant was at 35ml/hr.Difficulty placing the catheter in the left leg occurred.An all groups disabled alarm displayed.The nurse was in the intensive care unit (icu) with the patient and could not get the control unit (cu) to run.Troubleshooting was performed; however, the alarm persisted.The patient was brought back to the catheterization lab for catheter replacement.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X40CM
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14458997
• Report Number: 2134265-2022-05639
• Device Sequence Number: 4503949
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 06/17/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2023
• Device Model Number: 500-55140
• Device Catalogue Number: 500-55140
• Device Lot Number: 0010447379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• 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 Sex: Unknown