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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Device Problem Entrapment of Device (1212)
Patient Problem Cardiogenic Shock (2262)
Event Date 03/31/2023
Event Type  Death  
Event Description
It was reported that the patient died.A rotapro was selected for pre transcatheter aortic valve implantation (tavi) procedure.During the procedure, the burr became stuck in the lesion after the first ablation due to the calcification and tortuosity.A several attempts were made to remove the burr using several techniques: buddy wire and a small balloon on the burr placed, used an extension guide wire with dynaglide mode, but it was unsuccessful.After several maneuvers to remove the burr, the patient died.As per physician's opinion, the patient was so weak and unstable with a very highly calcified and tortuous ductus arteriosus (da), the device or procedure did not cause or contribute to the patient complication as the patient's death was caused by cardiogenic shock.
 
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Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
model farm road
cork
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16771217
MDR Text Key313600449
Report Number2124215-2023-18691
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/19/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2023
Initial Date FDA Received04/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Required Intervention; Death;
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