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

Model Number	7526
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon failed to inflate.The 2.00 mm x 30 mm apex mr balloon catheter was selected for use.However, during the procedure the balloon did not inflate and was filled with blood.There were no patient complications reported.
Additional Manufacturer Narrative
Returned product consisted of an apex balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube of the device.There was blood and contrast in the hub, inflation lumen, and the balloon.There was blood in the guidewire lumen, and the balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located on the proximal end of the proximal markerband.The device failed to inflate to rated burst pressure.Product analysis confirmed the reported event, as during functional testing the device was found to have a pinhole damage to the balloon.
Event or Problem Description
It was reported that the balloon failed to inflate.The 2.00 mm x 30 mm apex mr balloon catheter was selected for use.However, during the procedure the balloon did not inflate and was filled with blood.There were no patient complications reported.

• Brand Name: APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18039210
• Report Number: 2124215-2023-60638
• Device Sequence Number: 18025214
• Product Code: LOX
• UDI-Device Identifier: 08714729475828
• UDI-Public: 08714729475828
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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: 11/14/2024
• Device Model Number: 7526
• Device Catalogue Number: 7526
• Device Lot Number: 0028384541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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 Sex: Unknown