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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 45038
Device Problem Improper Flow or Infusion (2954)
Patient Problem Bradycardia (1751)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
Age at time of event - 18 years or older.
 
Event Description
It was reported that patient experienced bradycardia.The 100% stenosed, concentric and de novo target lesion was located in the left pulmonary artery.After a 6 fr guide catheter and 0.035 guidewire was inserted, an angiojet pe catheter was advanced for a thrombectomy procedure.The angiojet ultra console was then set to power pulse mode, however, it was noticed that blood was being lightly aspirated into the catheter line and collection bag.After under 20 seconds of use, the catheter was replaced with another angiojet pe catheter.Blood continued to be lightly aspirated during power pulse.No damage was observed with either catheter.It was noted that the patient experienced transient bradycardia and halted power pulse temporarily and within a few seconds bradycardia subsided.The physician thought that the bradycardia was related to the use of the angiojet device as it subsided when power pulse was stopped.The physician decided to proceed with the procedure and it was completed with technical and clinical success.No further patient complications were reported and patient's status was stable.
 
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Brand Name
ANGIOJET ULTRA SYSTEM CONSOLE
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
500 commander shea boulevard
quincy MA 02171
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10823233
MDR Text Key215884372
Report Number2134265-2020-15634
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 11/11/2020
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? Yes
Device Operator Health Professional
Device Model Number45038
Device Catalogue Number45038
Device Lot NumberOEMTRACE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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