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

Model Number	6532
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device broke.During preparation and while outside the patient, a 15mm x 4.00mm nc quantum apex broke.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
Event or Problem Description
It was reported that a device broke.During preparation and while outside the patient, a 15mm x 4.00mm nc quantum apex broke.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.It was further reported that the device was found to be broken when it was taken out of the box and the device was not used inside the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was a separation of the hypotube 86.9cm from the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded, and there was blood and contrast present in the folds.The device also has tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported break as there was separation to the device.

• 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
• MDR Report Key: 11848781
• Report Number: 2134265-2021-06504
• Device Sequence Number: 17080766
• Product Code: LOX
• UDI-Device Identifier: 08714729783411
• UDI-Public: 08714729783411
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 10/29/2023
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0026266785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1