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

Model Number	6533
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 20mm x 2.50mm nc quantum apex balloon catheter was advanced for dilation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen.The rapid port exchange and tip of the device were damaged.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.At the rapid port exchange the guidewire lumen was punctured exposing the inflation lumen and causing the device to leak.The device failed to inflate to rated burst pressure.
Event or Problem Description
It was reported that balloon rupture occurred.A 20mm x 2.50mm nc quantum apex balloon catheter was advanced for dilation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• 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: 12554301
• Report Number: 2134265-2021-11974
• Device Sequence Number: 16389506
• Product Code: LOX
• UDI-Device Identifier: 08714729783466
• UDI-Public: 08714729783466
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 05/09/2024
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0027280199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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: Unknown