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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 7313
Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2019
Event Type  malfunction  
Event Description
It was reported that the balloon was torn and disintegrated.The 85% stenosed target lesion was located in the mid left anterior descending artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced to treat the lesion.However, the device failed to cross, and the balloon was torn and disintegrated during procedure.No patient complications were reported.
 
Event Description
It was reported that the balloon was torn and disintegrated.The 85% stenosed target lesion was located in the mid left anterior descending artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced to treat the lesion.However, the device failed to cross, and the balloon was torn and disintegrated during procedure.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and blood in the guidewire lumen.Microscopic inspection revealed a pinhole 3mm distal from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
 
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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 Key8685654
MDR Text Key147600654
Report Number2134265-2019-06073
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 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/25/2020
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0022985722
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2019
Date Manufacturer Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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