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

Model Number 500-55112

Device Problems Device Alarm System (1012); Difficult to Remove (1528)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

It was reported that there was removal difficulty.A 106x12cm ekosonic endovascular device was selected for the index procedure.The device was inserted and had air bubbles in the drug line that had to be aspirated, so the catheter was not able to be forward flushed.About 30 minutes into the therapy, while the patient was being transferred, an occlusion alarm sounded.At that point, the patient was returned to the table to pull out the infusion catheter to replace it with a new one.As the physician was removing the catheter, however, the catheter kept "catching" on something.There was a struggle to remove the catheter.The physician had to pinch the wire with a hemostat to hold it in place while pulling the infusion catheter back.The catheter was able to be removed and a new catheter passed over the wire smoothly.There were no further complications.The patient was doing well and ultimately received the correct dose of lytic.

Event Description

It was reported that there was removal difficulty.A 106x12cm ekosonic endovascular device was selected for the index procedure.The device was inserted and had air bubbles that had to be aspirated, so the catheter was not able to be forward flushed.About 30 minutes into the therapy, while the patient was being transferred, an occlusion alarm sounded.At that point, the patient was returned to the table to pull out the catheter to replace it with a new one.As the physician was removing the catheter, however, the catheter kept "catching" on something.There was a struggle to remove the catheter.The physician had to pinch the wire with a hemostat to hold it in place while pulling the infusion catheter back.The catheter was able to be removed and a new catheter passed over the wire smoothly.There were no further complications.The patient was doing well and ultimately received the correct dose of lytic.

Manufacturer Narrative

Device evaluated by manufacturer: the ic was returned with the cable cut; no usc was returned.No kinks or additional damage that would have contributed to the report of withdraw difficulty were observed.The device was able to be flushed without issue.The device was loaded into a bend jig with a guidewire inserted.The device was withdrawn with no difficulty or indication that the device was catching.The site complaint was not confirmed.

• 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): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15825103
• MDR Text Key: 307525559
• Report Number: 2124215-2022-45978
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035072136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 150 KG
• Patient Race: Black Or African American