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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 7133
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Used (b)(6) 2019 as event date as there was no date provided.
 
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary artery.A 3.50mm x 15mm emerge balloon catheter was selected; however, the balloon ruptured before going into the patient.No harm or complications were done to the patient.
 
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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 Key8341481
Report Number2134265-2019-01315
Device Sequence Number2138149
Product Code LOX
UDI-Device Identifier08714729806257
UDI-Public08714729806257
Combination Product (Y/N)N
Initial Reporter StateKY
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) 02/14/2019
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 Date02/24/2021
Device Model Number7133
Device Catalogue Number7133
Device Lot Number22321488
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/28/2019
Initial Report FDA Received Date02/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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