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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
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 presented with severe multifocal restenosis in a large posterior ventricular branch, which presented accentuated tortuosity.A guidezilla catheter was inserted in the proximal third of the posterior ventricular artery.A 15mm x 2.50mm nc quantum apex balloon catheter was advanced for dilatation.However, during inflation at 16 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with severe multifocal restenosis in a large posterior ventricular branch, which presented accentuated tortuosity.A guidezilla catheter was inserted in the proximal third of the posterior ventricular artery.A 15mm x 2.50mm nc quantum apex balloon catheter was advanced for dilatation.However, during inflation at 16 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.The shipping wire was in place within the device upon product return and was able to be removed.There was contrast in the inflation lumen and blood in the guidewire lumen.At the rapid port exchange, there was shaft damage to the inflation lumen consistent to an interaction with a guidewire.The shaft was not punctured through, but it did distort the shaft.The balloon was loosely folded.At 3mm from the tip moving proximally for a length of 7mm, the balloon has a longitudinal tear.Product analysis confirmed the reported burst, as there was a longitudinal tear in the balloon.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12790654
• Report Number: 2134265-2021-14163
• Device Sequence Number: 4788416
• Product Code: LOX
• UDI-Device Identifier: 08714729783350
• UDI-Public: 08714729783350
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 03/01/2024
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0026896522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male