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

Model Number 500-56140

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  Injury  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 293092286
• Report Number: 2134265-2022-06181
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K183361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention