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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since event date was not provided.
 
Event Description
It was reported that shaft break occurred. A 20mm x 3. 25mm nc quantum apex balloon catheter was advanced for dilatation. Balloon was intact and fine when it was opened from the package. However, upon inflation, it was fractured in the middle of the wire and completely broke off from the system. The balloon was able to be retrieved from the body with a guide extension catheter. The procedure was completed with a different device. No further patient complications nor injuries reported.
 
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Brand NameNC QUANTUM APEX
Type of DeviceCATHETERS, 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 Key13006535
MDR Text Key282272898
Report Number2134265-2021-15613
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6533
Device Catalogue Number6533
Device Lot Number0027384173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
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