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

Model Number	6531
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an air embolism occurred.The target lesion was located in the coronary artery.A 12mm x 2.75mm nc quantum apex balloon catheter was used for dilatation.However, upon pulling negative pressure, an air embolus was injected into the coronary artery.The balloon was removed as rupture was suspected, but when the device was removed from the patient the balloon was intact and they found a leak in the delivery line.The device was completely removed from the patient's body.The patient was then treated with medications and was now 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: 9712383
• Report Number: 2134265-2020-01388
• Device Sequence Number: 355495
• Product Code: LOX
• UDI-Device Identifier: 08714729783251
• UDI-Public: 08714729783251
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/14/2020

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: 08/26/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024332275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/14/2020
• 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