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

Model Number H7493912420250

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2018

Event Type  malfunction  

Event Description

Doctor doing an intervention on the right coronary artery (rca).When advancing the 2.5x20 nc quantum apex balloon over the wire, the wire did not exit in the proper place.The wire exited through the balloon.The balloon never entered the body.Boston scientific nc quantum apex 2.5x20.No harm to patient.Device is not available for return.

• 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
• MDR Report Key: 8027397
• MDR Text Key: 125781833
• Report Number: 8027397
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H7493912420250
• Device Lot Number: 21225573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA