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

Model Number	6531
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the right coronary artery.A 12mm x 3.50mm nc quantum apex balloon catheter was advanced for post dilation.However, during inflation, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the right coronary artery.A 12mm x 3.50mm nc quantum apex balloon catheter was advanced for post dilation.However, during inflation, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured at 18 atmospheres for 10 seconds.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the right coronary artery.A 12mm x 3.50mm nc quantum apex balloon catheter was advanced for post dilation.However, during inflation, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured at 18 atmospheres for 10 seconds.It was further reported that the issue of this complaint was the device failed to cross the lesion during procedure.

• 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: 10265158
• Report Number: 2134265-2020-09230
• Device Sequence Number: 3463438
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2020

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 Expiration Date: 10/21/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024636378
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 09/29/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 08/04/2020; 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1