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

Model Number	6531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on device analysis completed on 27-aug-2018.It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 12mm x 2.75mm nc quantum apex balloon catheter was advanced for dilation.However, it was noted that the shaft was kinked and cut off at 4-5cm just before the hemostatic valve.The device was removed and the procedure was completed with a new nc quantum apex balloon catheter and implantation of a stent.No patient complications nor injuries were reported.However, returned device analysis revealed shaft detached/separated.Returned product consisted of a nc quantum apex balloon catheter in two pieces.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 52.7cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported difficulty.

• 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: 7906159
• Report Number: 2134265-2018-61263
• Device Sequence Number: 1787415
• Product Code: LOX
• UDI-Device Identifier: 08714729783251
• UDI-Public: 08714729783251
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 09/25/2018

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: 05/11/2021
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0022111189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1