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

Model Number 6530

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 02/11/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

B2 outcomes attrib to adv event: corrected.

Event 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).

• Brand Name: NC QUANTUM APEX
• Type of Device: 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
• MDR Text Key: 286924729
• Report Number: 2134265-2022-02169
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female