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

Model Number	6530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 99.8cm from the hub and appears to have been kinked prior to separation.Microscopic examination revealed damage to the tip.There is blood present in the inflation lumen and guidewire lumen.The balloon is partially loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed on a 75% stenosed, mildly calcified and mildly tortuous lesion in the left anterior descending artery.While advancing the 8mm x 2.75mm nc quantum apex balloon through the guiding catheter, the balloon catheter shaft broke and the two parts were removed from the vessel.The procedure was successfully completed with a different device without issue or patient injury.

• 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: 8528618
• Report Number: 2134265-2019-03805
• Device Sequence Number: 2516137
• Product Code: LOX
• UDI-Device Identifier: 08714729783145
• UDI-Public: 08714729783145
• 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
• Report Date (Section B): 04/18/2019

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: 01/15/2022
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0023195552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1