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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 135CM 12CM TZ; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 135CM 12CM TZ; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 500-56112
Device Problems Material Integrity Problem (2978); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Event Description
It was reported that a guidewire perforated a catheter.An ekosonic infusion catheter was placed for treatment of pulmonary embolism.The catheter moved proximal to the treatment zone prior to inserting the ekosonic ultrasonic core.The infusion catheter was attempted to be re-wire with a non-boston scientific guidewire in order to reposition when the guidewire perforated the ekosonic catheter.The perforated catheter was removed and a new ekosonic catheter was used to complete the case.The patient is doing well.
 
Event Description
It was reported that a guidewire perforated a catheter.An ekosonic infusion catheter was placed for treatment of pulmonary embolism.The catheter moved proximal to the treatment zone prior to inserting the ekosonic ultrasonic core.The infusion catheter was attempted to be re-wire with a non-boston scientific guidewire in order to reposition when the guidewire perforated the ekosonic catheter.The perforated catheter was removed and a new ekosonic catheter was used to complete the case.The patient is doing well.
 
Manufacturer Narrative
H3: device evaluated by manufacturer: an infusion catheter (ic) and a ultrasonic core (usc) were returned to boston scientific for analysis.The infusion catheter is not the kitted ic to the returned usc.The device was inspected for any damage or irregularities.The ekos usc showed signs of use but no kinks or other damage were found.The infusion catheter showed signs of use.There were two obstructed coolant holes and a blood clot at the distal end.The ic was able to be flushed during decontamination and during analysis.The distal end clot opened enough during analysis to allow fluid to pass but the clot never fully dissipated.The ic was inspected with a microscope for a rupture but non was found.A guide wire was inserted and traversed the length of the catheter until it stopped at the clot at the distal marker band.Device analysis determined the condition of the returned device was not consistent with the reported information of damaged/defective.
 
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Brand Name
EKOSONIC KIT 135CM 12CM TZ
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12520611
MDR Text Key272977496
Report Number2134265-2021-11889
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
PMA/PMN Number
K182324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number500-56112
Device Catalogue Number500-56112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Date Manufacturer Received10/02/2021
Patient Sequence Number1
Treatment
TERUMO GLIDEWIRE; TERUMO GLIDEWIRE; TERUMO GLIDEWIRE
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