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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 Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
It was reported that device was contaminated.A 15mm x 2.50mm nc quantum apex was selected for use.However, the device was contaminated.No patient complications were reported.
 
Event Description
It was reported that device was contaminated.A 15mm x 2.50mm nc quantum apex was selected for use.However, the device was contaminated.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.The product mandrel and balloon protector were shipped in place with the returned device.There was no presence of blood or contrast in the device and the balloon was tightly folded.Product analysis could not confirm the reported contamination as the device presented no damage or irregularities.
 
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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 Key11963303
MDR Text Key255089604
Report Number2134265-2021-07415
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729783350
UDI-Public08714729783350
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,health
Type of Report Initial,Followup
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/15/2024
Device Model Number6532
Device Catalogue Number6532
Device Lot Number0026976560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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