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

Model Number	6533
Medical Device Problem Codes	Inflation Problem (1310); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Agent ide study it was reported that a positioning problem occurred.In april 2022, the subject presented with stable angina and was randomized into the agent ide study and the index procedure was performed on the same day.Heparin or antithrombotic medication and gp iib/iiia inhibitor were administered at the time of index procedure.The subject was on a prior regimen of aspirin and antiplatelet medication other than aspirin (>= 72 hours) at the time of index procedure.A loading dose of 324 mg of aspirin and 600 mg of clopidogrel were given prior to the procedure.The 70% in-stent restenosed target lesion was located at the distal right coronary artery (rca) and was 15 mm long with a reference vessel diameter of 4.0 mm.The target lesion was predilated with 4.0 mm x 20 mm balloon with 20% residual stenosis with timi flow 3.Following pre-dilation, the lesion was treated with 4.0 mm x 20 mm nc quantum apex.Slipping of the balloon was noted, but the target lesion was treated successfully with 15% residual stenosis and timi flow 3.The subject was discharged on aspirin and prasugrel.
Additional Manufacturer Narrative
H6 device codes: corrected.
Event or Problem Description
Agent ide study.It was reported that an inflation problem occurred.In april 2022, the subject presented with stable angina and was randomized into the agent ide study and the index procedure was performed on the same day.Heparin or antithrombotic medication and gp iib/iiia inhibitor were administered at the time of index procedure.The subject was on a prior regimen of aspirin and antiplatelet medication other than aspirin (>= 72 hours) at the time of index procedure.A loading dose of 324 mg of aspirin and 600 mg of clopidogrel were given prior to the procedure.The 70% in-stent restenosed target lesion was located at the distal right coronary artery (rca) and was 15 mm long with a reference vessel diameter of 4.0 mm.The target lesion was predilated with 4.0 mm x 20 mm balloon with 20% residual stenosis with timi flow 3.Following pre-dilation, the lesion was treated with 4.0 mm x 20 mm nc quantum apex.Slipping of the balloon was noted, but the target lesion was treated successfully with 15% residual stenosis and timi flow 3.The subject was discharged on aspirin and prasugrel.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15691070
• Report Number: 2124215-2022-43650
• Device Sequence Number: 15130340
• Product Code: LOX
• UDI-Device Identifier: 08714729783527
• UDI-Public: 08714729783527
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/07/2022

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: 03/06/2025
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0028996300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Race: White