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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 7516
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/05/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The 90% stenosed target lesion with a 90 degrees significant bend was located in a non-calcified and severely tortuous fistula.A 4.00 mm x 8 mm apex balloon catheter was advanced over an.014 inch non-boston scientific guidewire.However, both devices became tangled inside the abdominal aorta.The physician removed the balloon and guidewire together.The procedure was aborted.No patient complications were reported and the patient's condition was stable.
 
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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 Key11178267
Report Number2134265-2021-00125
Device Sequence Number11362191
Product Code LOX
UDI-Device Identifier08714729475446
UDI-Public08714729475446
Combination Product (Y/N)N
Initial Reporter StateFL
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) 01/15/2021
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 Date10/01/2023
Device Model Number7516
Device Catalogue Number7516
Device Lot Number0026110417
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/05/2021
Initial Report FDA Received Date01/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age72 YR
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