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

Model Number	6531
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the mildly calcified and mildly tortuous left anterior descending artery (lad).A 12mm x 3.00mm nc quantum apex mr was advanced to the lad.Following inflation and deflation, a broken portion of the balloon was noticed.To remove the detached portion of the device, all systems including guidewire, guide catheter, and balloon device were drawn back together, and removed from the patient.It was noted that the fracture occurred approximately at the middle part of the catheter.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 42.5cm from the strain relief.The separated ends were jagged and ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen, and the balloon was tightly folded.Photo media reviewed aligns with analysis as photo depicts separation of hypotube as well as some of the hypotube kinks.
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the mildly calcified and mildly tortuous left anterior descending artery (lad).A 12mm x 3.00mm nc quantum apex mr was advanced to the lad.Following inflation and deflation, a broken portion of the balloon was noticed.To remove the detached portion of the device, all systems including guidewire, guide catheter, and balloon device were drawn back together, and removed from the patient.It was noted that the fracture occurred approximately at the middle part of the catheter.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.

• 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: 13672471
• Report Number: 2134265-2022-02477
• Device Sequence Number: 5475031
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 11/03/2024
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0028325407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White