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

Model Number 500-55112

Device Problem Obstruction of Flow (2423)

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

Event Date 01/14/2023

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: the patient was 33 years old at the time of study enrollment.The initial reporter was unable to specify which ekosonic endovascular device experienced the drug occlusion during the procedure.There are three possible serial numbers for this device: (b)(4).

Event Description

(b)(4) hi-peitho clinical study.It was reported that there was a line occlusion during the procedure.On (b)(6) 2023, the patient was enrolled in the clinical study, and the index procedure was performed on the same day.Ekosonic endovascular devices were used in conjunction with an ekos control system 4.0.The catheters were used without the use of ultrasound.One ekosonic endovascular device was successfully placed in the right pulmonary artery and one ekosonic endovascular device was successfully placed in the left pulmonary artery.Therapy was initiated at a rate of 1 mg/hr for a total dose of 2 mg across both catheters.There was a line occlusion, and the physician was unable to deliver bolus.The catheter was exchanged to complete the procedure.There were no adverse consequences reported for the patient.

Event Description

S2479 hi-peitho clinical study.It was reported that there was a line occlusion during the procedure.On (b)(6) 2023, the patient was enrolled in the clinical study, and the index procedure was performed on the same day.Ekosonic endovascular devices were used in conjunction with an ekos control system 4.0.The catheters were used without the use of ultrasound.One ekosonic endovascular device was successfully placed in the right pulmonary artery and one ekosonic endovascular device was successfully placed in the left pulmonary artery.Therapy was initiated at a rate of 1 mg/hr for a total dose of 2 mg across both catheters.There was a drug line occlusion, and the physician was unable to deliver bolus.The catheter was exchanged to complete the procedure.There were no adverse consequences reported for the patient.It was further reported that the physician was unable to flush the medication.It was further reported that when therapy was attempted to be initiated, the drug line occlusion occurred prior to any tissue plasminogen activator (tpa) being administered.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the patient was 33 years old at the time of study enrollment.The following fields have been updated for the first supplemental report: g4- premarket / 510(k)#: k183361; k182324.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the patient was 33 years old at the time of study enrollment.The following fields have been updated for the first supplemental report: g4- premarket / 510(k)#: k183361; k182324.

Event Description

S2479 hi-peitho clinical study.It was reported that there was a line occlusion during the procedure.On january 14, 2023, the patient was enrolled in the clinical study, and the index procedure was performed on the same day.Ekosonic endovascular devices were used in conjunction with an ekos control system 4.0.The catheters were used without the use of ultrasound.One ekosonic endovascular device was successfully placed in the right pulmonary artery and one ekosonic endovascular device was successfully placed in the left pulmonary artery.Therapy was initiated at a rate of 1 mg/hr for a total dose of 2 mg across both catheters.There was a drug line occlusion, and the physician was unable to deliver bolus.The catheter was exchanged to complete the procedure.There were no adverse consequences reported for the patient.It was further reported that the physician was unable to flush the medication.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• 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: 16259434
• MDR Text Key: 308455215
• Report Number: 2124215-2023-03398
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K183361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2023
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 0011652066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EKOSONIC ENDOVASCULAR DEVICE; EKOSONIC ENDOVASCULAR DEVICE; EKOSONIC ENDOVASCULAR DEVICE; EKOSONIC ENDOVASCULAR DEVICE; EKOSONIC ENDOVASCULAR DEVICE; EKOSONIC ENDOVASCULAR DEVICE
• Patient Sex: Female
• Patient Ethnicity: Hispanic