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

Model Number 500-56140

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 03/05/2022

Event Type  malfunction  

Event Description

It was reported that there was difficulty removing the device.A 135x40cm ekosonic endovascular device was selected for a unilateral pulmonary artery occlusion procedure.During placement of the ekosonic endovascular device, the infusion catheter would not track contralaterally over the.035 inch guidewire.The infusion catheter kept getting stuck and eventually kinked.The device became difficult to remove, and after a short period of time, the wire and catheter were able to be removed together.The wire and catheter were able to be separated after removal from the patient; however, a different wire and a different ekosonic catheter were used to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

Device analysis by manufacturer: the device was inspected for any damage or irregularities.The usc was not returned.The returned ic had blood throughout the device showing signs of obvious use.The ic was found with a severe kink 1.5cm from the strain relief.A second less severe kink was located 69.7cm from the strain relief; the od ring gage failed at this location.The ic showed some damage in the form of wavy wires under the strain relief.A guidewire was advanced through the ic with some difficulty and loaded into a bend jig; an in-house usc was attempted to be loaded into the ic and was unable to make it past the first major kink at 1.5cm.

Event Description

It was reported that there was difficulty removing the device.A 135x40cm ekosonic endovascular device was selected for a unilateral pulmonary artery occlusion procedure.During placement of the ekosonic endovascular device, the infusion catheter would not track contralaterally over the.035 inch guidewire.The infusion catheter kept getting stuck and eventually kinked.The device became difficult to remove, and after a short period of time, the wire and catheter were able to be removed together.The wire and catheter were able to be separated after removal from the patient; however, a different wire and a different ekosonic catheter were used to complete the procedure.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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13957347
• MDR Text Key: 288287541
• Report Number: 2134265-2022-03443
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2023
• Device Model Number: 500-56140
• Device Catalogue Number: 500-56140
• Device Lot Number: 0010804352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1