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

Model Number	6531
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The 80-90% stenosed target lesion was located in the mildly tortuous and severely calcified coronary artery.A 12mm x 2.75mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure it was noticed that the balloon was lost in pressure and ruptured.The device was then pulled out from the patient body without anything left or needing to be snared or retrieved; but the shaft found snapped on the proximal portion of the catheter near the hub.The device was replaced, and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Update: (d4) lot number updated from batch unknown to 0030441571.(d4) expiration date updated from unknown to 10/27/2025.(d4) unique identifier (udi) # (b)(4).(h4) device manufacture date updated from unknown to 10/28/2022.(h6) device code updated from material rupture a0412 to inflation problem a0406.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The 80-90% stenosed target lesion was located in the mildly tortuous and severely calcified coronary artery.A 12mm x 2.75mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure it was noticed that the balloon was lost in pressure and ruptured.The device was then pulled out from the patient body without anything left or needing to be snared or retrieved; but the shaft found snapped on the proximal portion of the catheter near the hub.The device was replaced, and the procedure was completed.There were no patient complications reported.It was further reported that the lesion was located in the circumflex artery.Furthermore, the balloon did not rupture.The device was inflated at 12 atmospheres and the balloon would no longer inflate due to the fracture on the proximal end of the catheter near the hub.The break occurred 3-4 cm from the hub.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16902023
• Report Number: 2124215-2023-22946
• Device Sequence Number: 5561467
• Product Code: LOX
• UDI-Device Identifier: 08714729783251
• UDI-Public: 08714729783251
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 05/31/2023

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: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0030441571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown