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

Model Number	6533
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since event date was not provided.
Event or Problem Description
It was reported that shaft break occurred.A 20mm x 3.25mm nc quantum apex balloon catheter was advanced for dilatation.Balloon was intact and fine when it was opened from the package.However, upon inflation, it was fractured in the middle of the wire and completely broke off from the system.The balloon was able to be retrieved from the body with a guide extension catheter.The procedure was completed with a different device.No further patient complications nor injuries reported.
Additional Manufacturer Narrative
B3.Date of event: used the first day of the month of the bsc aware date since event date was not provided.Device evaluated by manufacturer: returned product consisted of a nc quantum apex balloon catheter.The device was visually and microscopically examined.There were numerous hypotube kinks to the device.There was a separation of the hypotube 82.6cm from the strain relief.The separated ends were ovaled in shape indicating the device was kinked prior to separation.The rapid port exchange was torn a total length of 2mm which indicates an interaction or difficulty with a guidewire.There was contrast in the inflation lumen, blood in the guidewire lumen, and the balloon was tightly folded.
Event or Problem Description
It was reported that shaft break occurred.A 20mm x 3.25mm nc quantum apex balloon catheter was advanced for dilatation.Balloon was intact and fine when it was opened from the package.However, upon inflation, it was fractured in the middle of the wire and completely broke off from the system.The balloon was able to be retrieved from the body with a guide extension catheter.The procedure was completed with a different device.No further patient complications nor injuries 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: 13006535
• Report Number: 2134265-2021-15613
• Device Sequence Number: 1816926
• Product Code: LOX
• UDI-Device Identifier: 08714729783497
• UDI-Public: 08714729783497
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2024
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0027384173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown