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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
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Used the first date of the month of the aware date as no event date was provided.
 
Event or Problem 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.There were no patient complications nor injuries reported.
 
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Brand Name
EMERGE
Common Device Name
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9177631
Report Number2134265-2019-12292
Device Sequence Number14107248
Product Code LOX
UDI-Device Identifier08714729806509
UDI-Public08714729806509
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K113220
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/10/2019
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
Operator of Device Health Professional
Device Expiration Date01/09/2022
Device Model Number7130
Device Catalogue Number7130
Device Lot Number0023794115
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/23/2019
Initial Report FDA Received Date10/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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