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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 7312
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.50mm x 12mm nc emerge balloon catheter successfully dilated a stent.The emerge balloon catheter caught the wire during deflation and the wire and catheter were entrapped.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.
 
Event Description
It was reported that catheter entrapment occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.50mm x 12mm nc emerge balloon catheter successfully dilated a stent.The emerge balloon catheter caught the wire during deflation and the wire and catheter were entrapped.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen.The balloon was loosely folded, and the device had tip damage.The guidewire used in the procedure was not returned for analysis and functional testing.Instead a 0.014 guidewire was used for the wire insertion test.The guidewire passed through device with no resistance or issues.It was inserted through both ends of the device and encountered no difficulties.Product analysis did not confirm the reported event, because the guidewire passed through the device with no resistance or issues.However, clinical circumstances could not be replicated.
 
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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 Key11829392
MDR Text Key250820946
Report Number2134265-2021-05957
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,distri
Type of Report Initial,Followup
Report Date 06/23/2021
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 Date01/12/2023
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0026617713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Initial Date Manufacturer Received 04/26/2021
Initial Date FDA Received05/14/2021
Supplement Dates Manufacturer Received06/08/2021
Supplement Dates FDA Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
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