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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 04/26/2021
Event Type  Injury  
Event Description
It was reported that vessel perforation occurred. The greater than 70% stenosed target lesion was located in the mildly calcified and non-tortuous left anterior descending artery (lad). Following deployment of a 28mm x 4. 50mm synergy xd drug-eluting stent and post dilation with a 20mm x 5. 00mm nc quantum apex balloon catheter, a vessel perforation was noted in the lad. The perforation was covered with a stent and pericardiocentesis was performed. The patient was stable post-procedure.
 
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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 Key11810293
MDR Text Key250188585
Report Number2134265-2021-06049
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6533
Device Catalogue Number6533
Device Lot Number0027076988
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2021
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: 05/11/2021 Patient Sequence Number: 1
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