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

Model Number 6531

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

Patient Problem Death (1802)

Event Date 01/04/2021

Event Type  Death  

Event Description

It was reported that the patient died.The de novo target lesion was located in the left anterior descending artery.A 12mm x 3.50mm nc quantum apex balloon catheter and a 2.00mm x 15mm maverick 2 balloon catheter were used during the procedure, and a 3.00x38mm synergy ii drug-eluting stent was deployed to treat the lesion.However, it was noted that the output was low.The patient developed a problem and subsequently died the next day.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11233516
• MDR Text Key: 228797785
• Report Number: 2134265-2021-00360
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (y/n): N
• Reporter Country Code: BG
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2023
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0026299007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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): Death