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

Model Number	6532
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a nc quantum apex balloon catheter.Visual examination revealed multiple kinks to the hypotube and core wire.The hypotube is separated 124 cm from the hub.The distal section of the device did not return for product analysis.The missing parts are the distal inflation lumen, entire guidewire lumen, marker band, balloon, and tip.Microscopic examination revealed no additional damages.There is blood in the inflation lumen and hub.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 15 mm x 5.00 mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure, the shaft of the balloon broke off.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was fine.

• 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: 8620704
• Report Number: 2134265-2019-05341
• Device Sequence Number: 298023
• Product Code: LOX
• UDI-Device Identifier: 08714729783435
• UDI-Public: 08714729783435
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 05/17/2019

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: 03/06/2022
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0023450396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1