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

Model Number 6532

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11767769
• MDR Text Key: 249221045
• Report Number: 2134265-2021-05623
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783381
• UDI-Public: 08714729783381
• Combination Product (y/n): N
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 91