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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX VG; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX VG; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 10707
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 11/08/2021
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-left anterior descending artery.During preparation, after the patient was already sedated, the device was leaking at the pump assembly (where the connection for the back/priming tube meets the bulb), failed to prime, and there was an error message.There was no extra device to use so the procedure was cancelled.They needed to borrow a catheter from another facility, so the patient was rescheduled to be brought back to the cath lab the following day.No patient complications 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-left anterior descending artery.During preparation, after the patient was already sedated, the device was leaking at the pump assembly (where the connection for the back/priming tube meets the bulb), failed to prime, and there was an error message.There was no extra device to use so the procedure was cancelled.They needed to borrow a catheter from another facility, so the patient was rescheduled to be brought back to the cath lab the following day.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the product return contained an angiojet spiroflex.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The device showed no signs of damage.A functional test was performed.The pump was placed 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.No damage or discrepancies were noted on the rest of the catheter upon visual inspection.
 
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Brand Name
ANGIOJET SPIROFLEX VG
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 Key12867593
MDR Text Key281193890
Report Number2134265-2021-14523
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729889441
UDI-Public08714729889441
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080806
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
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 Date06/30/2022
Device Model Number10707
Device Catalogue Number10707
Device Lot Number0026039298
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 Received11/24/2021
Supplement Dates Manufacturer Received12/01/2021
Supplement Dates FDA Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2020
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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