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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 Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
Reported lot numbers: lot number: 0023834733, expiration date: 03/08/2021, device manufacture date: 04/09/2019.Lot number: 0023648693, expiration date: 02/17/2021, device manufacture date: 03/21/2019.
 
Event Description
It was reported that an error message was displayed.The patient presented with st-elevated myocardial infarction (stemi) and thrombus was located in right coronary artery (rca).A manual aspiration of the clot was done prior to using angiojet thrombectomy.An angiojet spiroflex catheter was inserted into an angiojet ultra 5000a console.However, an error message was shown during priming of the catheter and the device was having issues fully priming after several attempts were made.After reinserting the catheter, the device was able to prime.At this point, the catheter was inserted into the patient.While trying to utilize the thrombectomy in the rca, another error message appeared.During removal of the first catheter, a large amount of saline was pooling in the drawer of the console.Another spiroflex was opened.A similar experience occurred with the second catheter.The second catheter never entered the patient after similar error messages appeared.The procedure was successfully completed with a different device.No complications were reported.The patient was stable after the procedure and will be brought back for further percutaneous coronary intervention (pci) at a later date.
 
Manufacturer Narrative
Reported lot numbers: lot number: 0023834733, expiration date: 03/08/2021, and device manufacture date: 04/09/2019.Lot number: 0023648693, expiration date: 02/17/2021, and device manufacture date: 03/21/2019.Device evaluated by mfr.: returned product consisted of the spiroflex thrombectomy system.The pump number was reviewed and confirmed to be from finished goods batch 23834733.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Inspection of the device revealed numerous kinks throughout the shaft.Functional testing was performed by placing the device in the angiojet ultra console.Testing consisted of running the complaint device through the full priming cycle and 120 seconds in thrombectomy.The device ran within normal range, without any leaks from the boot or pump assembly on the device and there were no console errors/alarms.
 
Event Description
It was reported that an error message was displayed.The patient presented with st-elevated myocardial infarction (stemi) and thrombus was located in right coronary artery (rca).A manual aspiration of the clot was done prior to using angiojet thrombectomy.An angiojet spiroflex catheter was inserted into an angiojet ultra 5000a console.However, an error message was shown during priming of the catheter and the device was having issues fully priming after several attempts were made.After reinserting the catheter, the device was able to prime.At this point, the catheter was inserted into the patient.While trying to utilize the thrombectomy in the rca, another error message appeared.During removal of the first catheter, a large amount of saline was pooling in the drawer of the console.Another spiroflex was opened.A similar experience occurred with the second catheter.The second catheter never entered the patient after similar error messages appeared.The procedure was successfully completed with a different device.No complications were reported.The patient was stable after the procedure and will be brought back for further percutaneous coronary intervention (pci) at a later date.
 
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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
MDR Report Key9348271
MDR Text Key169135787
Report Number2134265-2019-14051
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729889380
UDI-Public08714729889380
Combination Product (y/n)N
PMA/PMN Number
K072769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/12/2019
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 Date03/08/2021
Device Model Number10706
Device Catalogue Number10706
Device Lot Number0023834733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2019
Initial Date Manufacturer Received 10/30/2019
Initial Date FDA Received11/20/2019
Supplement Dates Manufacturer Received12/09/2019
Supplement Dates FDA Received12/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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