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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 6530
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of an nc quantum apex balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There was a kink 83cm distal from the strain relief. There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen. The balloon was loosely folded. Microscopic inspection revealed tip damage. There was a longitudinal tear 9mm long starting 1mm proximally from the proximal marker band. The device was functionally tested with a. 014 inch. The guidewire was unable to advance past the proximal marker band due to a kink on the inner shaft. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis found a longitudinal tear on the balloon and was unable to fully insert a guidewire.
 
Event Description
Reportable based on device analysis completed on 26nov2019. A 8mm x 3. 00mm nc quantum apex balloon catheter was received with no issues reported. However, returned device analysis revealed a balloon torn longitudinal.
 
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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 Key9438028
MDR Text Key175901392
Report Number2134265-2019-15080
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729783152
UDI-Public08714729783152
Combination Product (y/n)N
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2022
Device Model Number6530
Device Catalogue Number6530
Device Lot Number0023124068
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2019
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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