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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA PE; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA PE; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45029
Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Event Description
It was reported that an error message occurred: an angiojet pe catheter was selected for use in a thrombectomy procedure.The catheter was attempted be to be primed, but a check saline error message appeared.Priming was attempted again, and the catheter successfully primed.The catheter was advanced to the target lesion, and power pulse mode was activated.However, an error message occurred.The catheter was switched to thrombectomy mode, but another error occurred.It was noted the catheter pump was filled with saline and leaking onto the drawer.The catheter was removed and exchanged for a new angiojet catheter.The new catheter was used to complete the procedure.No patient complications occurred.
 
Manufacturer Narrative
Device evaluated by mfr.: the product return contained an angiojet pe.The assembly, supply line, shaft, saline supply and tip were all visually examined for potential damage.The shaft of the device was separated, leaving a large gap in the aspiration lumen from 25-27 cm on the shaft.A functional test could not be performed due to the damage on the device.
 
Event Description
It was reported that an error message occurred: an angiojet pe catheter was selected for use in a thrombectomy procedure.The catheter was attempted be to be primed, but a check saline error message appeared.Priming was attempted again, and the catheter successfully primed.The catheter was advanced to the target lesion, and power pulse mode was activated.However, an error message occurred.The catheter was switched to thrombectomy mode, but another error occurred.It was noted the catheter pump was filled with saline and leaking onto the drawer.The catheter was removed and exchanged for a new angiojet catheter.The new catheter was used to complete the procedure.No patient complications occurred.
 
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Brand Name
ANGIOJET ULTRA PE
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11047917
MDR Text Key222762724
Report Number2134265-2020-18250
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/29/2021
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
Device Operator Health Professional
Device Expiration Date02/25/2021
Device Model Number45029
Device Catalogue Number45029
Device Lot Number0023674448
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received12/21/2020
Supplement Dates Manufacturer Received09/08/2021
Supplement Dates FDA Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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