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

Model Number	6532
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by mfr: nc quantum apex mr 15mm x 2.00mm was returned for analysis.A visual and tactile examination identified no issues with the shaft of the device, and no issues identified with the distal extrusion.A microscopic examination identified a pinhole in the proximal part of the distal markerband of the balloon.Tip showed no signs of tip damage.A microscopic examination of the markerband identified no damage.An encore inflation unit was used to inflate the balloon to 20 atmospheres.
Event or Problem Description
Reportable based on device analysis completed on 25-sep-2024.It was reported that shaft leak were encountered.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.Pre-dilatation was performed with a 15 mm x 2.00 mm nc quantum apex balloon catheter, and while inflating, the balloon started leaking contrast at 4 atmospheres.The device was removed, and the procedure was completed with a different device.However, returned device analysis revealed balloon pinhole.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20486929
• Report Number: 2124215-2024-65069
• Device Sequence Number: 3615570
• Product Code: LOX
• UDI-Device Identifier: 08714729783336
• UDI-Public: 08714729783336
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 05/21/2026
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0031672345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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
• Patient Race: Asian