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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 6533
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
Event Type  malfunction  
Event Description
It was reported that entrapment of device occurred.The 80% stenosed target lesion was located in mildly tortuous and mildly calcified mid left anterior descending artery.A 20mm x 2.50mm nc quantum apex was advanced for dilatation and inflated to 20 atmospheres.However, during the procedure, the device got stuck on a non-boston scientific guidewire.The balloon and guidewire were both removed from the patient's body simultaneously as one unit.It was noted that the balloon was deflated prior to removal and was removed from the patient intact.The procedure was completed with another of same device.There were no patient complications reported.
 
Event Description
It was reported that entrapment of device occurred.The 80% stenosed target lesion was located in mildly tortuous and mildly calcified mid left anterior descending artery.A 20mm x 2.50mm nc quantum apex was advanced for dilatation and inflated to 20 atmospheres.However, during the procedure, the device got stuck on a non-boston scientific guidewire.The balloon and guidewire were both removed from the patient's body simultaneously as one unit.It was noted that the balloon was deflated prior to removal and was removed from the patient intact.The procedure was completed with another of same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was blood and contrast present in the manifold, inflation lumen and the balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At 3mm from the tip, moving proximally for a length of 12mm, there was a longitudinal tear in the balloon.The guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The guidewire passed through device with no resistance or issues.The guidewire was inserted through both the exit notch and the tip of the device and encountered no difficulties.The guidewire passed through the device with no resistance or issues, however, clinical circumstances could not be replicated.The unreported longitudinal tear is damage that could occur during procedural use due to an interaction with patient characteristics, over inflation, or an interaction with another device.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14381192
MDR Text Key291595728
Report Number2134265-2022-04728
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729783466
UDI-Public08714729783466
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6533
Device Catalogue Number6533
Device Lot Number0028816437
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE USED: RUNTHROUGH 185CM; GUIDEWIRE USED: RUNTHROUGH 185CM
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