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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
Lot Number 28133044
Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 01/31/2022
Event Type  malfunction  
Event Description
During cardiac catheterization revascularization procedure, there was rupture of balloon in the stented segment post dilation. This caused the balloon to entrap within the stented segment. The distal tip of the balloon disengaged from the shaft. Initial capture of the distal tip of the balloon was accomplished with a snare and pulled into the guide but then it became embolized into the lad (left anterior descending artery). There were multiple wires placed into the lad to try to pull the balloon tip back into the guide, ultimately a 4mm snare was able to trap the distal tip and the entire system was removed. The balloon tip was visualized outside the body. The procedure was successfully completed.
 
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Brand NameNC QUANTUM APEX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key13541261
MDR Text Key285673670
Report Number13541261
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number28133044
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2022
Date Report to Manufacturer02/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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