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

Model Number	6530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the femoral artery.The 92% stenosed, 8mm x 3.50mm, concentric, de novo target lesion was located in the moderately tortuous and severely calcified left main artery.A 8mm x 3.50mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure, the physician noticed that the balloon shaft was broken.The device was removed intact and the procedure was completed with a different device.No patient complications were 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 was a separation of the hypotube 71.6cm from the strain relief.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen and balloon, and the balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the femoral artery.The 92% stenosed, 8mm x 3.50mm, concentric, de novo target lesion was located in the moderately tortuous and severely calcified left main artery.A 8mm x 3.50mm nc quantum apex balloon catheter was advanced for dilatation.However, during the procedure, the physician noticed that the balloon shaft was broken.The device was removed intact and the procedure was completed with a different device.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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12658054
• Report Number: 2134265-2021-13065
• Device Sequence Number: 11070503
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: 07/07/2022
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0024066158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2019
• 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 Age: 69 YR
• Patient Sex: Male