MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 135CM 50CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-56150

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/01/2021

Event Type  malfunction  

Event Description

It was reported that removal difficulty occurred.An ekosonic endovascular device was selected for use during a deep vein subclavian thrombolysis.The infusion catheter was entered through the femoral vein without issue.When the ultrasonic core was advanced it was difficult to advance through the sheath.At this time, the device was then removed and difficultly removing the catheter was also noted.Upon examination post removal, the tip was noted to be kinked.The procedure was completed with another ekosonic catheter.No patient complications were reported.

Manufacturer Narrative

The ekos infusion catheter (ic) and ultrasonic core (usc) were returned to boston scientific for analysis.The infusion catheter and usc were inspected for any damage or irregularities.The usc showed signs of use.Kinks were noted 66.2 cm, 100.5 cm and 112.2 cm along the length of the usc.The ic device showed damage in the form of kinks 29.5 cm and under the strain relief.The ic failed the outer diameter ring gage test at 30 cm from the strain relief.Testing was able to pass a in house guidewire through the ic and load the ic through a bend jig but with extreme resistance.The usc was then inserted into the ic and did transcend the catheter but with extreme resistance.Secondary finding of the kink in the infusion catheter is most probably attributable to unintended use error caused or contributed to event.Device analysis determined the condition of the returned device was consistent with the reported information.

Event Description

It was reported that removal difficulty occurred.An ekosonic endovascular device was selected for use during a deep vein subclavian thrombolysis.The infusion catheter was entered through the femoral vein without issue.When the ultrasonic core was advanced it was difficult to advance through the sheath.At this time, the device was then removed and difficultly removing the catheter was also noted.Upon examination post removal, the tip was noted to be kinked.The procedure was completed with another ekosonic catheter.No patient complications were reported.

• Brand Name: EKOSONIC KIT 135CM 50CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12528966
• MDR Text Key: 273330013
• Report Number: 2134265-2021-11891
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (y/n): N
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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: 02/15/2023
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 0010155057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 10/02/2021
• Supplement Dates FDA Received: 10/22/2021
• Patient Sequence Number: 1