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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 500-55112
Device Problems Device Alarm System (1012); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
Event Type  malfunction  
Event Description
It was reported that there was an unresolved drug occlusion within the catheter.A 106cm 12cm tz ekosonic catheter was selected for use to treat pulmonary embolism in a covid positive patient on a ventilator operating at 80% and oxygen saturation level at 92%.About 1 hour and 45 minutes into therapy, a down stream occlusion alarm occurred on the left side catheter.Per instructions from the clinical specialist the nurse attempted to flush the occluded catheter with normal saline (ns) solution.The nurse tried to flush forward several times without success.At the time, there had been no tissue plasminogen activator (tpa) infusing through the catheter for about an hour because they were waiting for additional supply.Both the drug infusion and ultrasound were turned off on the left side catheter until additional tpa became available.A drug infusion pump alert was also noted on the right side.Troubleshooting occurred; however, it is unclear whether the issues were resolved.No patient complications were reported.
 
Event Description
It was reported that there was an unresolved drug occlusion within the catheter.A 106cm 12cm tz ekosonic catheter was selected for use to treat pulmonary embolism in a covid positive patient on a ventilator operating at 80% and oxygen saturation level at 92%.About 1 hour and 45 minutes into therapy, a down stream occlusion alarm occurred on the left side catheter.Per instructions from the clinical specialist the nurse attempted to flush the occluded catheter with normal saline (ns) solution.The nurse tried to flush forward several times without success.At the time, there had been no tissue plasminogen activator (tpa) infusing through the catheter for about an hour because they were waiting for additional supply.Both the drug infusion and ultrasound were turned off on the left side catheter until additional tpa became available.A drug infusion pump alert was also noted on the right side.Troubleshooting occurred; however, it is unclear whether the issues were resolved.No patient complications were reported.
 
Manufacturer Narrative
Updates: d4: model number, lot number, catalog number, expiration date, serial number, unique identifier (udi) #.H4: device manufacture date.H6: evaluation conclusion codes.
 
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Brand Name
EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
Type of Device
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 Key12597743
MDR Text Key275428753
Report Number2134265-2021-12499
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006134
UDI-Public00858593006134
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number500-55112
Device Catalogue Number500-55112
Device Lot Number8035034368
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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