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

Model Number	6530
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was treated for coronary artery disease for lesion located in a de novo vessel.An 8mm x 3.50mm nc quantum apex balloon catheter was selected for use.However, it was noted that the balloon ruptured before use.The procedure was completed with a non-boston scientific device.No patient complications were reported and the patient condition was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was treated for coronary artery disease for lesion located in a de novo vessel.An 8mm x 3.50mm nc quantum apex balloon catheter was selected for use.However, it was noted that the balloon ruptured before use.The procedure was completed with a non-boston scientific device.No patient complications were reported and the patient condition was stable.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older.Device evaluation by mfr: returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the hypotube and shaft of device.There was blood in the guidewire lumen.The balloon was loosely folded and had an 8mm longitudinal tear at tip transition.

• 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: 11556174
• Report Number: 2134265-2021-03772
• Device Sequence Number: 4047954
• Product Code: LOX
• UDI-Device Identifier: 08714729783176
• UDI-Public: 08714729783176
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 11/12/2023
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0026348535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1