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

Model Number	6531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft break occurred.The patient presented with coronary artery disease.The 90% stenosed target lesion was located in the severely tortuous and severely calcified artery.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during removal of the device, the distal end of the shaft was fractured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B5 describe event or problem updated.D4 updated: 1.Lot number from 0031062553 to 0031641512.2.Expiration date from 02/15/2026 to 05/16/2026.3.Unique identifier (udi) # updated.E2 health professional corrected from yes to no.E3 occupation corrected from (b)(6).
Event or Problem Description
It was reported that the shaft break occurred.The patient presented with coronary artery disease.The 90% stenosed target lesion was located in the severely tortuous and severely calcified artery.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during removal of the device, the distal end of the shaft was fractured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the target lesion was located in the mid left anterior descending artery.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 23.8cm from the strain relief.There were numerous kinks to the hypotube and shaft of the device.There was contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.Product analysis confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported that the shaft break occurred.The patient presented with coronary artery disease.The 90% stenosed target lesion was located in the severely tortuous and severely calcified artery.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during removal of the device, the distal end of the shaft was fractured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the target lesion was located in the mid left anterior descending artery.
Event or Problem Description
It was reported that the shaft break occurred.The patient presented with coronary artery disease.The 90% stenosed target lesion was located in the severely tortuous and severely calcified artery.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during removal of the device, the distal end of the shaft was fractured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the target lesion was located in the mid left anterior descending artery.

• 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: 17317149
• Report Number: 2124215-2023-36925
• Device Sequence Number: 3996274
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/30/2023

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: 05/16/2026
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0031641512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 08/01/2023; 08/23/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 07/21/2023; 08/09/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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
• Patient Sex: Unknown