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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 6532
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
Age at the time of event: 18 years or older.
 
Event Description
It was reported that catheter entrapment occurred. Vascular access was obtained via the femoral artery. The concentric target lesion was located in the left anterior descending artery. A 15mm x 3. 00mm nc quantum apex balloon catheter was advanced for post-dilatation. However, after the balloon was deflated, the physician attempted to remove the device, but it became stuck with the wire. The physician then decided to remove the whole system and the procedure was completed. No patient complications were reported and the patient's status was stable.
 
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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 Key9531462
MDR Text Key177150604
Report Number2134265-2019-16130
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6532
Device Catalogue Number6532
Device Lot Number0023807960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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