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

Model Number	6532
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft hole and air embolism occurred.The stenosed target lesion was located in the left coronary artery.A 15mm x 2.50mm nc quantum balloon catheter was advanced for dilation.The balloon was positioned at the site of the lesion, and when attempted to bring the balloon to a neutral state by pulling negative on the indeflator, it did not go neutral while preparing to inflate the balloon.Another attempt to inflate the balloon was performed and it was discovered that air had entered the artery, and the patient began to experience decompensation.Medications and cardiopulmonary resuscitation (cpr) were administered to stabilize the patient.It was determined that air had been injected into the coronary artery due to a hole in the balloon shaft at the monorail port.The device was removed, and the procedure was completed with another of the same device.The patient condition has fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr.: nc quantum apex balloon catheter was returned for analysis.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon.There was blood in the inflation lumen, guidewire lumen, and the balloon.The balloon was loosely folded.There was twisting to the shaft just proximal to the rapid port exchange entrance for a length of 4mm.Within the twisted shaft, there was a 3mm longitudinal tear.Product analysis confirmed the reported event, as the device was found to have a longitudinal tear and twisting to the shaft.
Event or Problem Description
It was reported that shaft hole and air embolism occurred.The stenosed target lesion was located in the left coronary artery.A 15mm x 2.50mm nc quantum balloon catheter was advanced for dilation.The balloon was positioned at the site of the lesion, and when attempted to bring the balloon to a neutral state by pulling negative on the indeflator, it did not go neutral while preparing to inflate the balloon.Another attempt to inflate the balloon was performed and it was discovered that air had entered the artery, and the patient began to experience decompensation.Medications and cardiopulmonary resuscitation (cpr) were administered to stabilize the patient.It was determined that air had been injected into the coronary artery due to a hole in the balloon shaft at the monorail port.The device was removed, and the procedure was completed with another of the same device.The patient condition has fully recovered.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17801319
• Report Number: 2124215-2023-50266
• Device Sequence Number: 7380413
• Product Code: LOX
• UDI-Device Identifier: 08714729783350
• UDI-Public: 08714729783350
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 05/22/2026
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0031679360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female