MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7516

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2021

Event Type  malfunction  

Event 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.

• Brand Name: APEX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11178267
• MDR Text Key: 227058366
• Report Number: 2134265-2021-00125
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729475446
• UDI-Public: 08714729475446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 7516
• Device Catalogue Number: 7516
• Device Lot Number: 0026110417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR