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	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the calcified descending artery.During the procedure, two 20mm x 2.50mm and a 20mm x 3.00mm nc quantum apex balloon catheters were used to dilate the lesion.However, during inflation at less than 14 atmospheres, the balloons ruptured.The devices were removed and upon checking the artery, the lesion was not dilated.A rotational atherectomy with a 1.75mm balloon was used to prepare the artery for stent implantation.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
The returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was contrast and blood in the inflation lumen and the balloon.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 13mm from the tip of the device there was a pinhole in the balloon.The device failed to inflate to rated burst pressure.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the calcified descending artery.During the procedure, two 20mm x 2.50mm and a 20mm x 3.00mm nc quantum apex balloon catheters were used to dilate the lesion.However, during inflation at less than 14 atmospheres, the balloons ruptured.The devices were removed and upon checking the artery, the lesion was not dilated.A rotational atherectomy with a 1.75mm balloon was used to prepare the artery for stent implantation.No patient complications were 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13699670
• Report Number: 2134265-2022-02546
• Device Sequence Number: 20322689
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 08/08/2024
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0027800955
• 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: 02/25/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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