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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 6534
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2020
Event Type  Injury  
Event Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery.A 30mm x 2.50mm nc quantum apex balloon catheter was advanced for dilation.During removal, the distal portion remained in patient due to a bend.The device was completely removed by trapping the wire and inflating another balloon.The procedure was completed with another of the same device and no further complications were reported.
 
Event Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery.A 30mm x 2.50mm nc quantum apex balloon catheter was advanced for dilation.During removal, the distal portion remained in patient due to a bend.The device was completely removed by trapping the wire and inflating another balloon.The procedure was completed with another of the same device and no further complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 56.8cm distal of the strain relief.The was blood in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other 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 Key10757988
MDR Text Key213857417
Report Number2134265-2020-14604
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729783572
UDI-Public08714729783572
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model Number6534
Device Catalogue Number6534
Device Lot Number0025653715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2020
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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