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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS Back to Search Results
Model Number 7130
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: used (b)(6) 2019 as the correct date was not provided.
 
Event Description
It was reported that balloon rupture occurred. A 2. 00mm x 8mm emerge balloon catheter was advanced for dilatation. However, during inflation below the rated burst pressure, the balloon ruptured. No patient complications were reported.
 
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Brand NameEMERGE
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 SCIMED, INC
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9537109
MDR Text Key177153718
Report Number2134265-2019-16296
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7130
Device Catalogue Number7130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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