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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3520
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Asystole (4442)
Event Date 07/07/2021
Event Type  Death  
Event Description
It was reported that slow flow occurred and the patient died.The target lesion was located in the very calcified left anterior descending artery (lad).A 1.25mm rotapro and 330cm rotawire and wireclip torquer were selected for use.A 7f guide extension catheter was placed within a 7f guide catheter through a previously placed drug-eluting stent in the left main.The rotapro system was successfully delivered and several runs of rotablation were performed in the mid lad segment.Once the mid segment was passed, rotablation was successfully performed in the distal segment.In-between the runs, several contrast checks were made.There was never a dissection or a perforation, but there was a little bit of slow flow.The rotapro system was successfully retrieved and once the burr was outside the patient, the patient had a cardiac arrest.Reanimation was started and the lad was stented with a covered stent.There was no dissection after the final angio check.There was good flow in the lad, but there was no contractility in the ventricle anymore (asystole).The physician expects that there was too much debris that closed the micro circulation and the patient died after a long time of reanimation.
 
Event Description
It was reported that slow flow occurred and the patient died.The target lesion was located in the very calcified left anterior descending artery (lad).A 1.25mm rotapro and 330cm rotawire and wireclip torquer were selected for use.A 7f guide extension catheter was placed within a 7f guide catheter through a previously placed drug-eluting stent in the left main.The rotapro system was successfully delivered and several runs of rotablation were performed in the mid lad segment.Once the mid segment was passed, rotablation was successfully performed in the distal segment.In-between the runs, several contrast checks were made.There was never a dissection or a perforation, but there was a little bit of slow flow.The rotapro system was successfully retrieved and once the burr was outside the patient, the patient had a cardiac arrest.Reanimation was started and the lad was stented with a covered stent.There was no dissection after the final angio check.There was good flow in the lad, but there was no contractility in the ventricle anymore (asystole).The physician expects that there was too much debris that closed the micro circulation and the patient died after a long time of reanimation.It was further reported that the reported cause of death was slow flow.There were no performance issues with the rotapro or the rotawire.The vessel was not tortuous.The vessel was severely calcified.Total run time was approximately 7 minutes.
 
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Brand Name
ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12153458
MDR Text Key261083250
Report Number2134265-2021-08836
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729195566
UDI-Public08714729195566
Combination Product (y/n)N
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/26/2021
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? No
Device Operator Health Professional
Device Expiration Date06/18/2022
Device Model Number3520
Device Catalogue Number3520
Device Lot Number0025614361
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/07/2021
Initial Date FDA Received07/12/2021
Supplement Dates Manufacturer Received07/14/2021
Supplement Dates FDA Received07/26/2021
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
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