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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 6534
Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2018
Event Type  malfunction  
Event Description
It was reported that removal difficulties were encountered.A 30mm x 3.50mm nc quantum apex balloon catheter was used for dilatation.After deflating the balloon, the device was attempted to be removed; however, the device does not slide easily and got stuck with the guide.After several attempts, the device was able to be removed and the procedure was completed.No patient complications were reported.
 
Event Description
It was reported that removal difficulties were encountered.A 30mm x 3.50mm nc quantum apex balloon catheter was used for dilatation.After deflating the balloon, the device was attempted to be removed; however, the device does not slide easily and got stuck with the guide.After several attempts, the device was able to be removed and the procedure was completed.No patient complications were reported.However, the device returned for analysis was a 30mm x 2.50mm nc quantum apex balloon catheter.
 
Manufacturer Narrative
Lot number corrected from 0022172109 to 0022539944.Expiration date corrected from 05/25/2021 to 08/19/2021.Unique identifier (udi) corrected from (b)(4) to (b)(4).Device manufacture date corrected from 05/26/2018 to 08/20/2018.Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter from batch 22539944.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 that the tip is damaged and the balloon is loosely folded.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.A 0.014 test guidewire was inserted into the device.The device was inflated to rated burst pressure and then deflated to replicate the customers statement.The test guide wire could be removed without any difficulties.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported sticking to the guidewire.
 
Manufacturer Narrative
Lot number corrected from 0022539944 to 0022172109.Expiration date corrected from 08/19/2021 to 05/25/2021.Unique identifier (udi) corrected from (b)(4) to b)(4).Device manufacture date corrected from 08/20/2018 to 05/26/2018.Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter from batch 22172109.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed kinks at 42.5cm, 59cm, and 111cm from the hub.Microscopic examination revealed multiple buckling to the guidewire lumen.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.Per product specification, a 0.014 test guidewire was inserted into the device.The test guide wire could not pass thru the guidewire lumen.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed a guidewire would have difficulty being inserted or removed from the device because of the buckling.
 
Event Description
It was reported that removal difficulties were encountered.A 30mm x 3.50mm nc quantum apex balloon catheter was used for dilatation.After deflating the balloon, the device was attempted to be removed; however, the device does not slide easily and got stuck with the guide.After several attempts, the device was able to be removed and the procedure was completed.No patient complications were reported.However, the device returned for analysis was a 30mm x 2.50mm nc quantum apex balloon catheter.
 
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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 Key8048089
MDR Text Key126521053
Report Number2134265-2018-62644
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729783619
UDI-Public08714729783619
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
Type of Report Initial,Followup,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/25/2021
Device Model Number6534
Device Catalogue Number6534
Device Lot Number0022172109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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