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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 12mm x 2.50mm nc quantum apex balloon catheter was selected for use.However, during procedure, it was noticed that the balloon shaft broke.The guide was pulled out with the balloon shaft in it.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.The hypotube was separated 78.5cm from the hub, the separated ends were ovaled indicating that the separation was due to a kink prior to separation.There were also numerous kinks throughout the hypotube.The reported shaft separation was confirmed.
Event or Problem Description
It was reported that shaft break occurred.A 12mm x 2.50mm nc quantum apex balloon catheter was selected for use.However, during procedure, it was noticed that the balloon shaft broke.The guide was pulled out with the balloon shaft in it.

• 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: 9416451
• Report Number: 2134265-2019-14610
• Device Sequence Number: 2579122
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/14/2020

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 Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024371484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1