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

Model Number	500-56150
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ultrasonic core broke.An ekosonic kit 135cm 50cm tz was selected for use to treat deep vein thrombosis (dvt).The ekos infusion catheter was advanced into place without any issues.The ultrasonic inner core was advanced into the infusion catheter, however, it would only advance approximately two thirds of the way into the catheter.It was removed and flushed.A standard.035 guidewire was advanced to check for any obstructions; none were found.Fluoroscopy showed no signs of any kinks in the catheter.The ultrasonic inner core was advanced again, and became stuck.When it was attempted to be removed, it broke inside the catheter.The entire catheter including the broken component were successfully removed.Another catheter was selected for use to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) med center.Device eval by mfr: the ultrasonic core and the infusion catheter were returned for investigation.The device was inspected for any damage or irregularities.The infusion catheter had kinks 4mm, 60.3 cm, 62.3 cm and 121.2 cm from the strain relief.The od (outer diameter) ring gage test of the infusion catheter failed 62.3 cm from the distal end of the strain relief due to the kink in the catheter.Accordion damage (severe multiple kinks) was found under the strain relief.The usc was returned in 2 pieces with 1 piece still stuck in the ic.The available section of the usc measured 90.0 cm from the luer barb to the separation.Kinking was noted along the entire body of the usc.The additional section of the usc was noted still in the ic and measured 50 cm from the strain relief of the ic.The complaint of a break was confirmed.
Event or Problem Description
It was reported that the ultrasonic core broke.An ekosonic kit 135cm 50cm tz was selected for use to treat deep vein thrombosis (dvt).The ekos infusion catheter was advanced into place without any issues.The ultrasonic inner core was advanced into the infusion catheter, however, it would only advance approximately two thirds of the way into the catheter.It was removed and flushed.A standard.035 guidewire was advanced to check for any obstructions; none were found.Fluoroscopy showed no signs of any kinks in the catheter.The ultrasonic inner core was advanced again, and became stuck.When it was attempted to be removed, it broke inside the catheter.The entire catheter including the broken component were successfully removed.Another catheter was selected for use to complete the procedure.There were no patient complications.

• Brand Name: EKOSONIC KIT 135CM 50CM TZ
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13592624
• Report Number: 2134265-2022-01568
• Device Sequence Number: 5913123
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035024135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown