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

Model Number	6532
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion as located in the severely tortuous and calcified left anterior descending artery.A 2.50x20mm synergy ii drug-eluting stent was advanced for treatment.However, the device was unable to be delivered.When it was removed from the patient's body, it was noticed that the proximal edge of the stent struts were damaged.Another stent of the same sized was advanced to the lesion.Subsequently, a 1.2mm x 12mm threader balloon catheter was advanced but it failed to cross the lesion.Another 15mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The physician grabbed another balloon and completed the procedure.No patient complications were reported and the patient's status 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: 8429519
• Report Number: 2134265-2019-02620
• Device Sequence Number: 240564
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: 01/03/2022
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0023138114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1