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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 Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2020
Event Type  malfunction  
Event Description
It was reported that catheter entrapment on guidewire occurred. A 3. 50mm x 15mm nc emerge balloon catheter was advanced for use. However, upon withdrawal, the balloon was unable to re-wrap and was trapped in the guidewire. The guidewire was removed together with the balloon. No patient complications reported and the patient's status was stable.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10213402
MDR Text Key196986051
Report Number2134265-2020-07986
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/07/2022
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0025003791
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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