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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 Break (1069); Entrapment of Device (1212)
Patient Problem No Patient Involvement (2645)
Event Date 12/16/2019
Event Type  malfunction  
Event Description
It was reported that balloon catheter entrapment and a shaft break occurred.A 4.00mm x 15mm nc emerge balloon catheter was selected for treatment.However, the balloon catheter got stuck on the wire and the shaft broke while outside the patient.No known patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.The shaft was separated and stretched 116cm from the hub.The inner shaft was also separated; however, an accurate measurement of the separation was unable to be taken.The separated ends were stretched and jagged consistent with tensile overload.There were numerous buckled locations throughout the inner shaft.The guidewire use in the patient was not returned for analysis.The reported break was confirmed.
 
Event Description
It was reported that balloon catheter entrapment and a shaft break occurred.A 4.00mm x 15mm nc emerge balloon catheter was selected for treatment.However, the balloon catheter got stuck on the wire and the shaft broke while outside the patient.No known patient complications were reported.
 
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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 Key9554345
MDR Text Key177378129
Report Number2134265-2019-16269
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 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/03/2021
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0023429168
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Date Manufacturer Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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