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

Model Number	6530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft break occurred.The 70% stenosed target lesion was located in the mildly calcified and moderately tortuous right coronary artery (rca).A 8mm x 3.0mm nc quantum apex was used to dilate the target lesion.The balloon was inflated to 20 atmospheres on the first inflation and during the second inflation at 22 atmospheres, the balloon lost all pressure.During withdrawal of the balloon, the catheter broke at the distal end, approximately 15cm from the tip.At first, only the catheter was retrievable without the balloon.A trapping technique was then performed to retrieve the balloon and the tip of the catheter.The device was completely removed and the procedure was completed.There was no harm to the patient.

• 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: 8670113
• Report Number: 2134265-2019-05927
• Device Sequence Number: 11308355
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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 Expiration Date: 01/22/2022
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0023230190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/05/2019
• 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