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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK651
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969)
Event Date 01/13/2018
Event Type  Death  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr#2134265-2018-00872, 2134265-2018-01625, 2134265-2018-01626, and 2134265-2018-01627. It was reported that st elevation myocardial infarction (stemi) and death occurred. A 4. 00mmx32mm synergy stent was advanced but was unable to cross the target lesion. At some time during the procedure three emerge balloons, a 2. 00x20mm, a 3. 0x20mm, and a 3. 0x30mm, were used along with a 3. 5x15mm nc quantum balloon. The patient was reported to have experienced stemi and subsequently died.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Also same case as mdr# 2134265-2018-02211. Previously it was reported that st elevation myocardial infarction (stemi) occurred during the procedure but now it is reported the patient presented with stemi. It was further reported that the 100% stenosed target lesion was located in a severely calcified, non-tortuous, mid to distal right coronary artery (rca). The 3. 0x20mm emerge balloon was used first, followed by the 3. 0x30mm and 2. 0x20mm emerge balloons, and the 3. 5x15mm nc quantum balloon. Prior to the patient's death, angioplasty, thrombectomy, and stenting with a 3. 5 x 32 synergy ii stent were performed. The patient died due to cardiac arrest. The physician did not consider the patient's death to be related to these devices.
 
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Brand NameNC QUANTUM APEX BALLOON CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7278349
MDR Text Key100320504
Report Number2134265-2018-01628
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
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK651
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 Received02/23/2018
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

Patient Treatment Data
Date Received: 02/16/2018 Patient Sequence Number: 1
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