MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56112
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportable based on further information received on (b)(6) 2023 and device analysis.It was reported that the infusion catheter (ic) was not working.An ekosonic endovascular device, 135x12cm was selected for use.The target lesion was located within the right pulmonary artery.When the ekosonic device was connected to the control unit (cu), there was an error message that indicated the ic was not connected.Troubleshooting was unable to resolve the issue.The ekosonic endovascular device was replaced in order to complete the procedure.There were no reported adverse consequences to the patient as a result of the malfunction, and the patient was stable following the procedure.However, device analysis revealed that the device was missing both marker bands from the ic, and the rounded tip from the ultrasonic core (usc).The customer was able to confirm that the marker bands were present on the device when it was removed from the patient.The customer was unable to confirm whether the usc tip may have detached during the procedure and was left in the patient.
Additional Manufacturer Narrative
Device analysis: initial inspection of the device showed that the device was missing both marker bands from the infusion catheter (ic), and the rounded tip from the ultrasonic core (usc).The device was connected to cu 4.0 console, which displayed an e322 alarm (all thermocouples invalid).The device dimensions were measured, and the usc measured 141.75cm from the luer barb, which was within the dimensional specifications for the usc.However, the ic measured approximately 141.5cm from the strain relief, which was out of specification.Additionally, the ic showed thin spots in the tubing and wavy wires, both indicative of stretching.Under microscopic evaluation, it was noticed that the thermocouple wires within the catheter were severed.It was likely that the catheter was stretched, causing the thermocouple wires to break within the catheter, which led to the e322 error message and confirmed the complaint.
Additional Manufacturer Narrative
Device analysis: initial inspection of the device showed that the device was missing both marker bands from the infusion catheter (ic), and the rounded tip from the ultrasonic core (usc).The device was connected to cu 4.0 console, which displayed an e322 alarm (all thermocouples invalid).The device dimensions were measured, and the usc measured 141.75cm from the luer barb, which was within the dimensional specifications for the usc.However, the ic measured approximately 141.5cm from the strain relief, which was out of specification.Additionally, the ic showed thin spots in the tubing and wavy wires, both indicative of stretching.Under microscopic evaluation, it was noticed that the thermocouple wires within the catheter were severed.It was likely that the catheter was stretched, causing the thermocouple wires to break within the catheter, which led to the e322 error message and confirmed the complaint.Updated fields: b5 h6 - patient code(s) - updated to more appropriately reflect the reported patient outcome.
Event or Problem Description
Reportable based on further information received on 02may2023 and device analysis.It was reported that the infusion catheter (ic) was not working.An ekosonic endovascular device, 135x12cm was selected for use.The target lesion was located within the right pulmonary artery.When the ekosonic device was connected to the control unit (cu), there was an error message that indicated the ic was not connected.Troubleshooting was unable to resolve the issue.The ekosonic endovascular device was replaced in order to complete the procedure.There were no reported adverse consequences to the patient as a result of the malfunction, and the patient was stable following the procedure.However, device analysis revealed that the device was missing both marker bands from the ic, and the rounded tip from the ultrasonic core (usc).The customer was able to confirm that the marker bands were present on the device when it was removed from the patient.The customer was unable to confirm whether the usc tip may have detached during the procedure.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EKOS CORP INC; 11911 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17009966
• Report Number: 2124215-2023-25805
• Device Sequence Number: 20591039
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K213422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 500-56112
• Device Catalogue Number: 500-56112
• Device Lot Number: 0011516590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown