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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 Deflation Problem (1149)
Patient Problem Bradycardia (1751)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 id: 2134265-2018-05597. It was reported that deflation failure occurred. The procedure was a complex intervention of the left coronary system. The target lesion was located in the 90% stenosis, normal calcification, non tortuos bifurcation of the ramus intermedius artery and the ramus interventricularis anterior artery. At the end of the procedure, the previously implanted stents were post-dilated with a nc quantum apex balloon catheter to achieve optimal results. The nc quantum apex balloon was inflated four times during post-dilation with an encore inflation device to a maximum pressure of 16 bar. Following the fourth inflation the encore inflation device was used to deflate the balloon and the pressure gauge did not respond accordingly. Several attempts were made to deflate the balloon by aspirating the encore syringe. This caused significant delay which resulted in a short term hemodynamic instability; lowering of the blood pressure and bradycardia. The encore inflation device was disconnected from the nc quantum apex balloon, retracted into the guiding catheter and the balloon was removed. There was a "lethal threat to the patient for a short time," but it was very quickly brought under control. The patient was not harmed and there was no consequential damage.
 
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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 Key7579398
MDR Text Key110418732
Report Number2134265-2018-05102
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received05/14/2018
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: 06/07/2018 Patient Sequence Number: 1
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