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

Model Number	6532
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that balloon rupture occurred.The target lesion was located in the mildly tortuous, and severely calcified left circumflex artery.A 15mm x 3.25mm nc quantum apex balloon catheter was advanced for dilation.However, during the initial inflation at 11 atmospheres for 5 seconds, the balloon ruptured.The device removed.And the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consists of an nc quantum apex balloon catheter.The device was visually and microscopically examined.It was noted that there were numerous kinks to the hypotube of the device, a contrast in the inflation lumen and blood in the guidewire lumen, and there was blood in the folds of the tightly folded balloon.The device was prepped with a new inflation device filled with water and connected to the inflation port to inflate the device.The device inflated to rated burst pressure and deflated with no issue.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the mildly tortuous and severely calcified left circumflex artery.A 15mm x 3.25mm nc quantum apex balloon catheter was advanced for dilation.However, during the initial inflation at 11 atmospheres for 5 seconds, the balloon ruptured.The device removed, and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• 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: 17184876
• Report Number: 2124215-2023-32227
• Device Sequence Number: 15068397
• Product Code: LOX
• UDI-Device Identifier: 08714729783381
• UDI-Public: 08714729783381
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 10/27/2025
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0030441589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Race: Asian