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

Model Number	6533
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since event date was not provided.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 38mm in length, 3.5 vessel diameter, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter was engaged and a non-bsc guide wire was crossed the lesion, a 20mm x 3.50mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure at 16 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
B3 date of event: corrected.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 38mm in length, 3.5 vessel diameter, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter was engaged and a non-bsc guide wire crossed the lesion, a 20mm x 3.50mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure at 16 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with different device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon ruptured during the first inflation for 20 seconds.

• Brand Name: NC QUANTUM 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16709830
• Report Number: 2124215-2023-13964
• Device Sequence Number: 20669283
• Product Code: LOX
• UDI-Device Identifier: 08714729783503
• UDI-Public: 08714729783503
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 06/16/2025
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0029607196
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 70 KG