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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3241
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiogenic Shock (2262)
Event Date 12/03/2023
Event Type  Death  
Event Description
It was reported that a patient death occurred.The patient presented for a complex left main to left anterior descending artery (lad) crossover procedure.It was noted that the left main was severely tortuous and heavily calcified.A 1.75mm rotalink rotablator plus was used for two runs of 11 seconds to ablate the calcium, then a wolverine 3.0 x 10mm and a synergy 3.0 x 32mm were used to treat the lesion; both were inflated at 11 atm.Afterwards, angio revealed timi3 flow without any dissection.After angio, however, the patient went into cardiac arrest and was immediately moved for emergency coronary artery bypass graft surgery.The patient passed away the next day due to cardiac tamponade which led to cardiogenic shock.
 
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Brand Name
ROTALINK PLUS
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18415165
MDR Text Key331575710
Report Number2124215-2023-73963
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729228370
UDI-Public08714729228370
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/27/2023
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? No
Device Operator Health Professional
Device Model Number3241
Device Catalogue Number3241
Device Lot Number0031714923
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/04/2023
Initial Date FDA Received12/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age57 YR
Patient SexFemale
Patient RaceAsian
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