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 Patient Involvement (2645)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a very tortuous circumflex artery.After advancing a 8 fr jr4 non-bsc guide catheter and crossing a samurai guide wire, a 3.0x20mm nc quantum balloon catheter was selected for use.Before introducing the device, the physician bent the shaft; however, the shaft snapped at approximately 24cm from the hub.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a very tortuous circumflex artery.After advancing a 8 fr jr4 non-bsc guide catheter and crossing a samurai guide wire, a 3.0x20mm nc quantum balloon catheter was selected for use.Before introducing the device, the physician bent the shaft; however, the shaft snapped at approximately 24cm from the hub.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.Returned product consisted of a nc quantum apex balloon catheter in two pieces.The balloon was loosely folded with dried blood between the balloon folds and along the shaft of the balloon catheter.Although it was reported that the device was not used, the presence of blood is indicative of handling beyond simply unpackaging the device, as was reported.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 60.8cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.The shaft is damaged at the exit notch.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.

• 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: 8019981
• Report Number: 2134265-2018-62448
• Device Sequence Number: 16492813
• Product Code: LOX
• UDI-Device Identifier: 08714729783480
• UDI-Public: 08714729783480
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 09/23/2021
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0022696865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1