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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3320
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Perforation (2001)
Event Date 11/29/2022
Event Type  Death  
Event Description
It was reported that perforation and death occurred.The patient presented with stable coronary artery disease for a rotational atherectomy procedure.There were visible aorto-coronary bypasses.Vascular access was obtained via the radial artery.The 90% stenosed, concentric target lesion was located in the non-tortuous and severely calcified left anterior descending artery.The lesion was less than 20mm in length and was 3.0-3.5mm in diameter.The 1.5mm rotalink burr was selected for use.No significant resistance was encountered while the device was in use.Following the procedure, a small perforation of the vessel was noted.The perforation was immediately treated with protamine and long duration balloon expansion.After a few minutes everything was all right.That evening the patient electrocardiogram showed something unusual and the patient was returned to the cath lab.The patient subsequently passed away on the table.
 
Manufacturer Narrative
E1.Initial reporter facility name corrected.
 
Event Description
It was reported that perforation and death occurred.The patient presented with stable coronary artery disease for a rotational atherectomy procedure.There were visible aorto-coronary bypasses.Vascular access was obtained via the radial artery.The 90% stenosed, concentric target lesion was located in the non-tortuous and severely calcified left anterior descending artery.The lesion was less than 20mm in length and was 3.0-3.5mm in diameter.The 1.5mm rotalink burr was selected for use.No significant resistance was encountered while the device was in use.Following the procedure, a small perforation of the vessel was noted.The perforation was immediately treated with protamine and long duration balloon expansion.After a few minutes everything was all right.That evening the patient electrocardiogram showed something unusual and the patient was returned to the cath lab.The patient subsequently passed away on the table.It was further reported that the perforation was at the lad proximal to the first diagonal and that the physician performed contract check which confirmed that the perforation was closed.The patient died due to myocardial infarction of circumflex artery.Per the physician, the event did not happen because of the rotational atherectomy.
 
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Brand Name
ROTALINK BURR
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15921014
MDR Text Key304864814
Report Number2124215-2022-50814
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeRS
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 Physician
Type of Report Initial,Followup
Report Date 12/14/2022
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 Number3320
Device Catalogue Number3320
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2022
Initial Date FDA Received12/05/2022
Supplement Dates Manufacturer Received11/30/2022
Supplement Dates FDA Received12/14/2022
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) Death;
Patient Age70 YR
Patient SexMale
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