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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 12/01/2021
Event Type  Injury  
Event Description
It was reported an intercranial hemorrhage occurred.The patient presented syncopated with a fulminant bilateral pulmonary arterial embolism (pae).The patient was stabilized and two 106cm 12cm tz ekos catheter's were implanted.After a few minutes one of the ekos catheters received a check catheter error, troubleshooting was unsuccessful, and the catheter was used as an infusion catheter only.Tpa was being delivered through both catheter with only one running ultrasound.Sometime later the patient experienced an intercranial hemorrhage (ich).The physician believes the ich was caused by the lysis drug tissue plasminogen activator (tpa).Additional information has been requested but unavailable at the time of this report.
 
Manufacturer Narrative
H6 device codes updated from - device displays incorrect message to - adverse event without identified device or use problem.
 
Event Description
It was reported an intercranial hemorrhage occurred.The patient presented syncopated with a fulminant bilateral pulmonary arterial embolism (pae).The patient was stabilized and two 106cm 12cm tz ekos catheter's were implanted.After a few minutes one of the ekos catheters received a check catheter error, troubleshooting was unsuccessful, and the catheter was used as an infusion catheter only.Tpa was being delivered through both catheter with only one running ultrasound.Sometime later the patient experienced an intercranial hemorrhage (ich).The physician believes the ich was caused by the lysis drug tissue plasminogen activator (tpa).Additional information has been requested but unavailable at the time of this report.
 
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Brand Name
EKOSONIC KIT 106CM 12CM TZ
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera propark
alajuela
CS  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13022908
MDR Text Key282386410
Report Number2134265-2021-15828
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K182324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age84 YR
Patient SexFemale
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