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

Model Number	7522
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a coronary artery.A 3.25mm x 15mm apex balloon catheter was advanced for dilation.However, during first inflation at 11 atmospheres for 15 seconds, the balloon ruptured.The device was removed and completed the procedure with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a coronary artery.A 3.25mm x 15mm apex balloon catheter was advanced for dilation.However, during first inflation at 11 atmospheres for 15 seconds, the balloon ruptured.The device was removed and completed the procedure with another of same device.There were no patient complications reported.It was further reported that this is the same device reported in emdr # 2124215-2022-37580.
Additional Manufacturer Narrative
Updated b5: describe event or problem.

• Brand Name: APEX
• Common Device Name: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15480301
• Report Number: 2124215-2022-37252
• Device Sequence Number: 5895188
• Product Code: LOX
• UDI-Device Identifier: 08714729475644
• UDI-Public: 08714729475644
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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 Date: 02/12/2024
• Device Model Number: 7522
• Device Catalogue Number: 7522
• Device Lot Number: 0026791998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 94 KG