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

Model Number	6531
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a hypotube separation 21.1cm from the strain relief.The separated ends of the hypotube were ovaled, indicating the hypotube was kinked prior to separation.At 103.6cm-104.1cm from the distal segment of the separation, the shaft was flattened.There was contrast in the inflation lumen and balloon.The balloon was tightly folded, and the tip of the device was damaged and prolapsed.Product analysis confirmed the reported break as there was separation to the device contributing to the reported crossing difficulty.The reported no cross in the lesion could not be confirmed as the clinical circumstances could not be replicated.
Event or Problem Description
Reportable based on device analysis completed on 30dec2021.It was reported that a shaft break occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, de novo target lesion with a significant bend of >= 90 degrees was located in the mildly tortuous and moderately calcified left anterior descending artery.A 12mm x 3.50mm nc quantum apex balloon catheter was advanced for dilation but did not cross the lesion after multiple attempts and the shaft broken 6cm from the hub.The procedure was completed with another of same device.There were no patient complications reported.The patient condition following the procedure was stable.However, device analysis revealed the break was 21cm from the hub, in a location which could enter the patient.

• 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: 13172938
• Report Number: 2134265-2022-00032
• Device Sequence Number: 17298250
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• 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
• Report Date (Section B): 01/05/2022

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: 12/22/2023
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0026556606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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 Age: 52 YR
• Patient Sex: Male