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	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 20mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation of the target lesion.However, during inflation, without exceeding the maximum rupture pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen and balloon.There was blood in the manifold, inflation lumen, and guidewire lumen.The balloon was loosely folded.At 5mm from the tip moving proximally for a length of 17mm, the balloon has a longitudinal tear.There was tip damage to the device.
Event or Problem Description
It was reported that balloon rupture occurred.A 20mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation of the target lesion.However, during inflation, without exceeding the maximum rupture pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

• 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: 13588784
• Report Number: 2134265-2022-02021
• Device Sequence Number: 12217222
• Product Code: LOX
• UDI-Device Identifier: 08714729783480
• UDI-Public: 08714729783480
• 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): 07/05/2022

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: 11/30/2023
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0026435519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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