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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7522
Medical Device Problem Code Deflation Problem (1149)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/27/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon deflation issue occurred.The target lesion was located in the left anterior descending artery.A 2.00mm x 15mm apex balloon catheter was advanced for pre-dilation.The balloon was inflated using a non-bsc indeflator with 50/50 omnipaque contrast at 6 atmospheres for 15 seconds.However, the physician encountered difficulty in inflating and deflating the balloon.The balloon was then managed to be fully deflated when removed.The procedure was completed as planned using a different device.No patient complications were reported.
 
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Brand Name
APEX
Common Device Name
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7991885
Report Number2134265-2018-62084
Device Sequence Number13756796
Product Code LOX
UDI-Device Identifier08714729475590
UDI-Public08714729475590
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P860019
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) 10/22/2018
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 Date08/27/2021
Device Model Number7522
Device Catalogue Number7522
Device Lot Number0022577557
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/27/2018
Initial Report FDA Received Date10/22/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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