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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7311
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Event Description
It was reported that the balloon froze on the wire.A percutaneous coronary intervention was being performed.A 3.50mm x 8mm nc emerge balloon catheter and a non-boston scientific guidewire were being used with the balloon being inflated to 12 atmospheres.After balloon deflation, the balloon was unable to be removed over the guidewire and became stuck.The balloon and guidewire were removed from the patient as a unit.The procedure was successfully completed.
 
Event Description
It was reported that the balloon froze on the wire.A percutaneous coronary intervention was being performed.A 3.50mm x 8mm nc emerge balloon catheter and a non-boston scientific guidewire were being used with the balloon being inflated to 12 atmospheres.After balloon deflation, the balloon was unable to be removed over the guidewire and became stuck.The balloon and guidewire were removed from the patient as a unit.The procedure was successfully completed.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.The inner shaft was buckled at the distal end of the balloon.There was an unknown guidewire in the device.The device was soaked in a water bath for one hour to loosen the blood and contrast in the device.The guidewire was removed after soaking the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that the device was frozen on the balloon.
 
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Brand Name
NC EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11423344
MDR Text Key238348167
Report Number2134265-2021-02845
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/21/2021
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 Date10/21/2022
Device Model Number7311
Device Catalogue Number7311
Device Lot Number0026222779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Initial Date Manufacturer Received 02/25/2021
Initial Date FDA Received03/05/2021
Supplement Dates Manufacturer Received04/19/2021
Supplement Dates FDA Received04/21/2021
Patient Sequence Number1
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