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

Model Number	6531
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a shaft break occurred: a percutaneous coronary intervention was being performed on a 75% stenosed, moderately calcified and moderately to severe tortuous lesion.A 12x3.00mm nc quantum apex balloon was difficult to track over the guidewire and the shaft of the balloon kinked.During pullback of the balloon the shaft fractured partly.The balloon was completely recovered and removed from the patient.The procedure was successfully completed with a different device without issue or patient injury.There were no adverse patient effects and the patient was stable.
Additional Manufacturer Narrative
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 79.1cm distal of the strain relief.There was contrast and blood in the inflation lumen.The balloon was loosely folded.The device was functionally tested with a.014 inch guidewire and no issues were detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
Event or Problem Description
It was reported a shaft break occurred.A percutaneous coronary intervention was being performed on a 75% stenosed, moderately calcified and moderately to severe tortuous lesion.A 12x3.00mm nc quantum apex balloon was difficult to track over the guidewire and the shaft of the balloon kinked.During pullback of the balloon the shaft fractured partly.The balloon was completely recovered and removed from the patient.The procedure was successfully completed with a different device without issue or patient injury.There were no adverse patient effects and the patient was stable.

• 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: 10466386
• Report Number: 2134265-2020-11950
• Device Sequence Number: 11423716
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 05/13/2023
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0025509224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR