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	Insufficient Information (4580)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 15mm x 3.25mm nc quantum apex balloon catheter was advanced for dilation, but failed to cross into the stent.However, upon removal, the device came apart into two separate pieces.No further information available.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the device.There was a separation of the hypotube 53.7cm from the strain relief.The separated ends of the hypotube were ovaled, indicating the hypotube was kinked prior to separation.There was contrast and blood in the inflation lumen.There was contrast in the loosely folded balloon.The device also had tip damage.The damage to the device is consistent to damage that can occur during preparation, use during the procedure, or post procedure.
Event or Problem Description
It was reported that shaft break occurred.A 15mm x 3.25mm nc quantum apex balloon catheter was advanced for dilation, but failed to cross into the stent.However, upon removal, the device came apart into two separate pieces.No further information available.

• 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: 11767769
• Report Number: 2134265-2021-05623
• Device Sequence Number: 3091694
• Product Code: LOX
• UDI-Device Identifier: 08714729783381
• UDI-Public: 08714729783381
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 12/03/2023
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0026456498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 91