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

Model Number	6531
Medical Device Problem Codes	Inflation Problem (1310); Failure to Advance (2524); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was unable to be inflated and the balloon was damaged.The 55% stenosed target lesion was located in the mildly tortuous and none calcified mid left anterior descending artery (lad).A 12mm x 2.50mm nc quantum apex balloon was selected for a percutaneous coronary intervention (pci).During procedure, a nc quantum apex device was advanced to the lesion site and the balloon failed to inflate.When the balloon was removed from the patient, the balloon was damaged.The procedure was successfully completed with another nc quantum apex balloon device and there were no complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a nc quantum apex balloon catheter.The device was microscopically and visually examined.There were no visual issues identified on the device.The balloon catheter was prepped with an inflation device filled with water to inflate the device to the rated burst pressure.The balloon was able to be inflated and maintained pressure as well as deflated with no issues.Product analysis did not confirm the reported failure to inflate, as during functional testing the balloon inflated to rated burst pressure and deflated with no issues.
Event or Problem Description
It was reported that the balloon was unable to be inflated and the balloon was damaged.The 55% stenosed target lesion was located in the mildly tortuous and none calcified mid left anterior descending artery (lad).A 12mm x 2.50mm nc quantum apex balloon was selected for a percutaneous coronary intervention (pci).During procedure, a nc quantum apex device was advanced to the lesion site and the balloon failed to inflate.When the balloon was removed from the patient, the balloon was damaged.The procedure was successfully completed with another nc quantum apex balloon device and there were no complications reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13978384
• Report Number: 2134265-2022-03777
• Device Sequence Number: 12288143
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 04/13/2024
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0027136853
• 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: 03/28/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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