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

Model Number	6532
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an incorrect compliance chart was in the packaging.The physician selected a 15mm x 2.75mm nc quantum apex to treat a 85% stenosed target lesion located in the non-tortuous and non-calcified left anterior descending artery (lad).Upon opening the package, a compliance chart for a 2.5 nc emerge was found in the packaging.The physician elected to use the 15mm x 2.75mm nc quantum apex.The patient experienced a dissection during the procedure requiring treatment with a 2.75x20 synergy stent.The procedure was completed.The patient was stable.

• 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: 9289639
• Report Number: 2134265-2019-13338
• Device Sequence Number: 1864635
• Product Code: LOX
• UDI-Device Identifier: 08714729783367
• UDI-Public: 08714729783367
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0023901478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/07/2019
• 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: Required Intervention