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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 24709
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified common iliac artery.A 4.0mmx30mmx143cm nc quantum apex was advanced for dilation.However, during first inflation at 10 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified common iliac artery.A 4.0mmx30mmx143cm nc quantum apex was advanced for dilation.However, during first inflation at 10 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr: device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.Microscopic examination revealed a pinhole in the balloon 12mm from the tip.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
 
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Brand Name
NC QUANTUM APEX
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9460887
MDR Text Key176379175
Report Number2134265-2019-15679
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/07/2021
Device Model Number24709
Device Catalogue Number24709
Device Lot Number0023607219
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Date Manufacturer Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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