Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 6532
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2020
Event Type  malfunction  
Event Description
It was reported that a balloon burst occurred.A 15mm x 3.50mm nc quantum apex balloon was advanced to the target lesion, and after inflation the balloon burst.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient condition after the procedure was good.
 
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 were numerous kinks.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole at the proximal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.
 
Event Description
It was reported that a balloon burst occurred.A 15mm x 3.50mm nc quantum apex balloon was advanced to the target lesion, and after inflation the balloon burst.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient condition after the procedure was good.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NC QUANTUM APEX
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9880147
MDR Text Key185024837
Report Number2134265-2020-03471
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729783398
UDI-Public08714729783398
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,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/04/2022
Device Model Number6532
Device Catalogue Number6532
Device Lot Number0024713081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Initial Date Manufacturer Received 03/02/2020
Initial Date FDA Received03/25/2020
Supplement Dates Manufacturer Received04/02/2020
Supplement Dates FDA Received04/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-