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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 6534
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myocardial Infarction (1969); Vasoconstriction (2126); Restenosis (4576)
Event Date 07/08/2021
Event Type  Injury  
Event Description
It was reported that myocardial infarction occurred. In (b)(6) 2021, the subject was referred for cardiac catheterization and the index procedure was performed on the same day. Heparin or antithrombotic medication gp iib/iiia inhibitor were administered at the time of index procedure. The subject was on a prior regimen of aspirin (>
=
72 hours) at the time of index procedure and loading dose of 300 mg of clopidogrel was given prior to the procedure. The target lesion 1 was located at the mid left anterior descending (lad) artery and was 24 mm long with a reference vessel diameter was 3. 00 mm. The target lesion was predilated with 3. 00 mm x 30 mm balloon with 30% residual stenosis. Following pre-dilation, the lesion was treated with 3. 00 mm x 30 mm nc quantum apex plain old balloon angioplasty (poba) successfully with 30% residual stenosis. Post-dilation was not performed. The baseline cardiac enzymes were as follows: ck-mb: 2. 6 ng/ml (reference range: 7. 7 ng/ml). Troponin t: 0. 199 ng/ml (reference range: 22 ng/ml). On the following day, elevation of ck-mb was noted consistent with protocol definition of myocardial infarction. Peak ck-mb: 113. 2 ng/ml (reference range: 7. 7 ng/ml). Electrocardiogram (ecg) was performed on the same day; however, ecg results are currently not available. The subject was diagnosed with myocardial infarction (mi) and the event led to prolongation of hospitalization. Per electronic data capture (edc), the rationale for diagnosis was symptoms and biomarker elevation. The location of myocardial infarction was not identifiable and was not q wave mi. Coronary angioplasty with agent balloon (crossover) was performed and medication was given to treat the event. Five days later, the subject was discharged. At the time of reporting, the event was ongoing.
 
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Brand NameNC QUANTUM APEX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12284835
MDR Text Key265340810
Report Number2134265-2021-09776
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6534
Device Catalogue Number6534
Device Lot Number0026625530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/05/2021 Patient Sequence Number: 1
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