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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION QUANTUM BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Failure to Advance (2524)
Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100); Vascular Dissection (3160)
Event Date 08/29/2018
Event Type  Injury  
Event Description
It was reported that thrombosis, dissection, chest pain and st segment elevation occurred. The patient presented with restenosis after multiple layers of stents were placed a couple of months ago. Vascular access was obtained via the femoral artery. The target lesion was located in the mid left anterior descending artery (lad). After a 3. 5mm non-bsc guide wire and another non-bsc wire were used to cross the lesion, an emerge balloon catheter was advanced for dilatation. A 3. 00 x 16mm synergy ii drug-eluting stent was implanted in the mid lad. A 3. 0x12mm nc quantum balloon catheter was advanced for post dilatation but the device failed to cross. A 3. 0x12mm non-bsc balloon was advanced and post dilation was performed and the stent looked fine. The patient went to recovery. However, a dissection was noted in the brachial area. Twenty to thirty minutes post stent deployment, st elevation and chest pain was experienced by the patient and was put back on the table. Vascular access was obtained via the left groin. A 3. 5mm non-bsc wire and another non-bsc wire were used. Thrombosis was noted in proximal lad to distal area. The lad was wired and ballooned and the flow was restored. Additional stent was implanted to cover the dissection with timi 3 flow post procedure. Patient was unstable with low blood pressure and atrial fibrillation. The patient was placed on three pressures, synchronized cardioverted. The patient was transferred to cardiovascular intensive care unit in critical condition. Patient was still conscious and alert on bilevel positive airway pressure. No further patient complications reported and the patient was stable.
 
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Brand NameQUANTUM BALLOON CATHETER
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 IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7898704
MDR Text Key121041814
Report Number2134265-2018-61199
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
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 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2018
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 Received08/29/2018
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: 09/21/2018 Patient Sequence Number: 1
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