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

Model Number	6533
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel perforation occurred.The greater than 70% stenosed target lesion was located in the mildly calcified and non-tortuous left anterior descending artery (lad).Following deployment of a 28mm x 4.50mm synergy xd drug-eluting stent and post dilation with a 20mm x 5.00mm nc quantum apex balloon catheter, a vessel perforation was noted in the lad.The perforation was covered with a stent and pericardiocentesis was performed.The patient was stable post-procedure.

• 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
• MDR Report Key: 11810293
• Report Number: 2134265-2021-06049
• Device Sequence Number: 11693452
• Product Code: LOX
• UDI-Device Identifier: 08714729783541
• UDI-Public: 08714729783541
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 04/01/2024
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0027076988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 44