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	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease.The target lesion was located in the left anterior descending artery.A 12mm x 2.50mm nc quantum apex balloon catheter was advanced for pre-dilation.However, it was noted that the shaft of the balloon broke while advancing into the lesion.The physician removed the whole system out and after that took an alternate access for completing the procedure.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Returned product consisted of an incomplete device return of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a separation of the shaft, 117.2cm from the strain relief.A total of 11.7cm of inflation lumen was returned and the full returned length of the lumen was stretched down.The guidewire lumen, balloon, markerbands, and tip failed to return for analysis.Product analysis confirmed the reported break as there was separation of the shaft to the device.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease.The target lesion was located in the left anterior descending artery.A 12mm x 2.50mm nc quantum apex balloon catheter was advanced for pre-dilation.However, it was noted that the shaft of the balloon broke while advancing into the lesion.The physician removed the whole system out and after that took an alternate access for completing the procedure.The procedure was completed with a different device.There were no patient complications reported and the patient status was 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14323656
• Report Number: 2134265-2022-04602
• Device Sequence Number: 4586884
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 01/24/2025
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0028740921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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