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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 Puncture/Hole (1504)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/10/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that shaft hole occurred.A 3.00mm x 15mm emerge balloon catheter was selected for dilatation.However, as the device was loaded onto the wire and when the device entered into the nose cone of the balloon, the wire exited the hypotube just beyond the balloon and made its own hole.The wire never actually made it to the monorail hole segment.The procedure was completed with a different device.There were no patient complications 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 Key8678066
Report Number2134265-2019-06258
Device Sequence Number2522276
Product Code LOX
UDI-Device Identifier08714729806233
UDI-Public08714729806233
Combination Product (Y/N)N
Initial Reporter StateFL
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 Physician
Type of Report Initial
Report Date (Section B) 06/07/2019
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 Date05/15/2021
Device Model Number7133
Device Catalogue Number7133
Device Lot Number0022665996
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2019
Initial Report FDA Received Date06/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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