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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 10706
Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.An angiojet spiroflex catheter was selected for a patient left heart catheterization to treat a large thrombus in the mid lad coronary artery.The target lesion was located in the mid-left anterior descending artery.During preparation, after the patient was sedated, the device was leaking at the pump assembly (where the white collar meets the bulb) and the catheter failed to prime.There was an error message.There was no extra device to use.The procedure was not completed and the patient had to be transferred to another facility for another attempt of the procedure.No patient complications were reported.
 
Manufacturer Narrative
H3: device return to manufacturer? corrected from "no" to "yes.".
 
Event Description
It was reported that the procedure was cancelled.An angiojet spiroflex catheter was selected for a patient left heart catheterization to treat a large thrombus in the mid lad coronary artery.The target lesion was located in the mid-left anterior descending artery.During preparation, after the patient was sedated, the device was leaking at the pump assembly (where the white collar meets the bulb) and the catheter failed to prime.There was an error message.There was no extra device to use.The procedure was not completed and the patient had to be transferred to another facility for another attempt of the procedure.No patient complications were reported.Were reported.
 
Event Description
It was reported that the procedure was cancelled.An angiojet spiroflex catheter was selected for a patient left heart catheterization to treat a large thrombus in the mid lad coronary artery.The target lesion was located in the mid-left anterior descending artery.During preparation, after the patient was sedated, the device was leaking at the pump assembly (where the white collar meets the bulb) and the catheter failed to prime.There was an error message.There was no extra device to use.The procedure was not completed and the patient had to be transferred to another facility for another attempt of the procedure.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device returned containing an angiojet spiroflex.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The device showed multiple kinks along the catheter.A functional test was performed by placing the pump into the ultra-drive console and the device primed with no complication.The device was run for a total time of 90 seconds in thrombectomy mode.The device stayed within the expected range of the product with average pressure.No damage or discrepancies were noted on the rest of the catheter upon visual inspection.H3: device return to manufacturer? corrected from "no" to "yes.".
 
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Brand Name
ANGIOJET SPIROFLEX
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12863877
MDR Text Key281203917
Report Number2134265-2021-14454
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729889380
UDI-Public08714729889380
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/14/2021
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 Date10/19/2022
Device Model Number10706
Device Catalogue Number10706
Device Lot Number0026568482
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2021
Initial Date FDA Received11/23/2021
Supplement Dates Manufacturer Received11/09/2021
12/01/2021
Supplement Dates FDA Received11/24/2021
12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2020
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 SexMale
Patient RaceBlack Or African American
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