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

Model Number	6530
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the balloon froze on the wire.A procedure was being completed with the use of a 8mm x 3.5mm nc quantum apex balloon catheter.As the balloon was being withdrawn after its use, it became stuck on the 190cm samurai guidewire.The balloon was not able to be removed by itself, so it was removed with the guidewire.There were no patient complications reported to have occurred.

• 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: 10135685
• Report Number: 2134265-2020-07745
• Device Sequence Number: 14358112
• Product Code: LOX
• UDI-Device Identifier: 08714729783176
• UDI-Public: 08714729783176
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/09/2020

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: 06/26/2020
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0021916574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1