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

Model Number	6530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6).It was reported that a dissection occurred.The target lesion was located in the distal left circumflex coronary artery (lcx) and was 8 mm long with a reference vessel diameter of 3.00 mm.The lesion was predilated using a 3.00 mm x 8 mm nc quantum apex balloon with 0% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was successfully treated with a 3.00 mm x 8 mm study device with 0% residual stenosis.Post dilation was not performed.On the same day, the patient was diagnosed with a distal edge dissection at the distal lcx.The dissection was treated with angioplasty using a 3.0 x 15 mm non-boston scientific drug eluting stent.The event was considered to be recovered / resolved.
Event or Problem Description
Agent ide it was reported that a dissection occurred.The target lesion was located in the distal left circumflex coronary artery (lcx) and was 8 mm long with a reference vessel diameter of 3.00 mm.The lesion was predilated using a 3.00 mm x 8 mm nc quantum apex balloon with 0% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was successfully treated with a 3.00 mm x 8 mm study device with 0% residual stenosis.Post dilation was not performed.On the same day, the patient was diagnosed with a distal edge dissection at the distal lcx.The dissection was treated with angioplasty using a 3.0 x 15 mm non-boston scientific drug eluting stent.The event was considered to be recovered / resolved.It was further reported that the subject presented with unstable angina.The dissection was diagnosed using intravascular ultrasound (ivus).
Additional Manufacturer Narrative
B2 outcomes attrib to adv event: corrected.

• 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: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13604771
• Report Number: 2134265-2022-02169
• Device Sequence Number: 5857454
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: 10/05/2024
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0028149693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female