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

Model Number	6532
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Chest Pain (1776); Vascular Dissection (3160); Reduced Blood Flow (4598)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection occurred.The patient presented with angina for a percutaneous transluminal coronary angioplasty in the right coronary artery (rca).The 70% stenosed lesion was located in a moderately tortuous and moderately calcified rca.A 15mm x 3.00mm nc quantum apex balloon catheter was selected for use.During the procedure, the balloon distally inflated inside the body at 12 atmospheres in first attempt, and the balloon shaft inflated leading to a flow limiting type a dissection in the ostio proximal rca.A chest pain occurred related to the dissection.A stent was deployed to cover the dissection, treated with a graft and the procedure was completed successfully.There were no further patient complications, and the patient was stabilized in the iccu (intensive coronary care unit) post procedure.
Event or Problem Description
It was reported that vessel dissection occurred.The patient presented with angina for a percutaneous transluminal coronary angioplasty in the right coronary artery (rca).The 70% stenosed lesion was located in a moderately tortuous and moderately calcified rca.A 15mm x 3.00mm nc quantum apex balloon catheter was selected for use.During the procedure, the balloon distally inflated inside the body at 12 atmospheres in first attempt, and the balloon shaft inflated leading to a flow limiting type a dissection in the ostio proximal rca.A chest pain occurred related to the dissection.A stent was deployed to cover the dissection, treated with a graft and the procedure was completed successfully.There were no further patient complications, and the patient was stabilized in the iccu (intensive coronary care unit) post procedure.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.However, media provided by the site was reviewed by boston scientific medical personnel and the images provided were found to be consistent with shaft rupture causing a proximal vessel dissection.

• Brand Name: NC QUANTUM 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: 16733063
• Report Number: 2124215-2023-17411
• Device Sequence Number: 20510593
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2025
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0030507043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown