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

Model Number	500-56150
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombus occurred.An ekosonic catheter was selected for use to treat a thrombus located in the superficial femoral artery (sfa).The thrombus was noted to be acute and chronic.Heparin was given at 12mg/hr and lytic at 1 mg/hr over the course of 24 hours.During treatment of the thrombus with the ekosonic catheter, the clot was not cleared up, and it increased in severity while the catheter was in place.The physician observed that the pulse was lost in the foot.The increase in thrombus was attributed to a catheter malfunction by the physician.The procedure was then completed the following day with a cdt catheter.There were no further patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned and analysis was completed.The device was inspected for any damage or irregularities.Both the ic and usc were cut at the cable, so the sn was unable to be confirmed and functional testing was unable to be performed.The ic showed no apparent damage, the device measured in specification.The usc showed no apparent damage and the device measured in specification.Microscopic inspection of the usc revealed a section of what appears to be an extra layer of shrink wrap that did not shrink that went from 115cm-117cm.
Event or Problem Description
It was reported that thrombus occurred.An ekosonic catheter was selected for use to treat a thrombus located in the superficial femoral artery (sfa).The thrombus was noted to be acute and chronic.Heparin was given at 12mg/hr and lytic at 1 mg/hr over the course of 24 hours.During treatment of the thrombus with the ekosonic catheter, the clot was not cleared up, and it increased in severity while the catheter was in place.The physician observed that the pulse was lost in the foot.The increase in thrombus was attributed to a catheter malfunction by the physician.The procedure was then completed the following day with a cdt catheter.There were no further 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: 13744542
• Report Number: 2134265-2022-02416
• Device Sequence Number: 4544787
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 05/24/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2024
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035058744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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 Sex: Female