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 Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 12mm x 2.50mm nc quantum apex balloon catheter was selected for dilatation.Upon opening the package in a sterile fashion, it was noticed that the shaft of the balloon was completely broken apart.The procedure was successfully completed with a different device.
Event or Problem Description
It was reported that break occurred.The target lesion was located in the coronary artery.A 12 mm x 2.50 mm nc quantum apex balloon catheter was selected for dilatation.Upon opening the package in a sterile fashion, it was noticed that the shaft of the balloon was completely broken apart.The procedure was successfully completed with a different device.It was further reported that the break occurred just proximal to the balloon.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the coronary artery.A 12 mm x 2.50 mm nc quantum apex balloon catheter was selected for dilatation.Upon opening the package in a sterile fashion, it was noticed that the shaft of the balloon was completely broken apart.The procedure was successfully completed with a different device.It was further reported that the break occurred just proximal to the balloon.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 49.7cm distal of the strain relief.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 11007686
• Report Number: 2134265-2020-17721
• Device Sequence Number: 3813945
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2021

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: 11/05/2023
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0026306785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 01/22/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/18/2020; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1