MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X24CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55124
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal marker band detached from the catheter, and remained in the patient.An ekosonic endovascular device, 106x24cm was selected for use in the iliac.The catheter was advanced to the target lesion, but was unable to pass due to severe stenosis.The catheter was attempted to be withdrawn, at which point the distal marker band detached.The physician elected to leave the device fragment in the patient, as there was a limited risk of the marker band migrating from the severe stenosis.The procedure was aborted at this time, and the patient was not treated.There were no further consequences reported for the patient.The patient was reported to be doing fine.
Additional Manufacturer Narrative
Device analysis: the ekosonic endovascular device was returned to the complaint investigation site.Only the infusion catheter (ic) was returned, no ultrasonic core (usc).During the visual inspection, it was noticed that there was a significant kink at 32cm from the strain relief on the ic.It was also noticed that the distal marker band was not present on the ic, confirming the reported event of the marker band detaching.
Event or Problem Description
It was reported that the distal marker band detached from the catheter, and remained in the patient.An ekosonic endovascular device, 106x24cm was selected for use in the iliac.The catheter was advanced to the target lesion, but was unable to pass due to severe stenosis.The catheter was attempted to be withdrawn, at which point the distal marker band detached.The physician elected to leave the device fragment in the patient, as there was a limited risk of the marker band migrating from the severe stenosis.The procedure was aborted at this time, and the patient was not treated.There were no further consequences reported for the patient.The patient was reported to be doing fine.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X24CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16639372
• Report Number: 2124215-2023-14589
• Device Sequence Number: 5434709
• Product Code: KRA
• UDI-Device Identifier: 00858593006158
• UDI-Public: 00858593006158
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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: 02/23/2025
• Device Model Number: 500-55124
• Device Catalogue Number: 500-55124
• Device Lot Number: 8035084443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male