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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 01/31/2020
Event Type  Injury  
Event Description
It was reported that dissection occurred and patient experienced chest pain. The patient presented with st-elevation myocardial infarction and the target lesion was located in the mid-right coronary artery. A 3. 0x24 synergy drug-eluting stent was implanted in the lesion area. However, after the patient went for recovery, a severe chest pain was felt and was returned to cath lab. It was found that the stent was occluded and so it was wired with a choice pt extra support. A 3. 0x12 nc quantum apex balloon catheter was used to re-open the artery, followed by an angiojet catheter to removed the clot from the stent and used ivus to interrogate it. A small dissection was noted in the proximal end of the stent and so a 3. 5x8 synergy des was placed in an overlapping fashion to the initially placed stent. Both devices were post dilated with a 3. 5x8 nc quantum balloon catheter. The stent was re-ivus again to confirm the apposition, expansion and treatment of the small dissection. Defibrillators were not used in this case. No further patient complications were reported.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9728803
MDR Text Key180411767
Report Number2134265-2020-01646
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received01/31/2020
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 Treatment Data
Date Received: 02/19/2020 Patient Sequence Number: 1
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