MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X40CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56140
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that additional intervention was required.A 135 x 40cm ekosonic endovascular device was selected for treatment.A few minutes after the ultrasound had been activated, an alarm was received on the pt3b control unit indicating the temperature was too high on the device.During troubleshooting with the ekos helpline, coolant flow was increased up to 100ml/ hour but the error was not resolved.The control unit was turned off and on, the cables were disconnected and checked for any moisture but the alarm remained unresolved.The catheter was eventually replaced and worked without any problems.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluation: the ekos infusion catheter (ic) and ultrasonic core (usc) were returned to boston scientific for analysis.The ic was returned with the connection cable cut.Due to this damage testing of the full device was impossible.Some wavy wires were found in the ic implying stretching of the device occurred during use.There was no visible damage to the usc seen.Functional testing was performed by plugging in the cut cable of the ic into the in-house control unit 4.0.A temperature alarm immediately appeared.Further testing was unavailable.It could not be confirmed if this alarm would have appeared had the cable not been cut.
Event or Problem Description
It was reported that additional intervention was required.A 135 x 40cm ekosonic endovascular device was selected for treatment.A few minutes after the ultrasound had been activated, an alarm was received on the pt3b control unit indicating the temperature was too high on the device.During troubleshooting with the ekos helpline, coolant flow was increased up to 100ml/ hour but the error was not resolved.The control unit was turned off and on, the cables were disconnected and checked for any moisture but the alarm remained unresolved.The catheter was eventually replaced and worked without any problems.There were no patient complications reported.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X40CM
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14566263
• Report Number: 2134265-2022-06181
• Device Sequence Number: 5083027
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: 500-56140
• Device Catalogue Number: 500-56140
• Device Lot Number: 0011516454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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