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

Model Number	6532
Medical Device Problem Codes	Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: nc quantum apex mr 15mm x 2.50mm was returned for analysis.Visual, tactile, microscopic, and leakage testing was performed on the device.Visual and tactile inspection found multiple hypotube kinks along the length of the shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.An attempt was made to inflate the device however inflation fluid began to leak through a pinhole in the balloon situated at 3mm from the proximal to the distal markerband.A detailed microscopic examination of the balloon material identified a pinhole at 3mm from the proximal to the distal markerband.Microscopic examination noted severe stretching in the inner lumen at 4.6cm proximal to the distal tip.A microscopic examination of the proximal and distal markerbands identified no damage.Tip showed no signs of tip damage.
Event or Problem Description
Reportable based on device analysis completed on 19dec2024.It was reported that balloon damaged occurred.The patient presented with coronary artery disease and was undergoing percutaneous transluminal coronary angioplasty.The target lesion was located in the right coronary artery.A 15mm x 2.50mm nc quantum apex balloon catheter was advanced for dilatation.However, while trying to cross the calcific target lesion, the balloon got damaged.Another device was used to complete the procedure successfully.No patient complications were reported.However, returned device analysis revealed that balloon had a 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: 21032587
• Report Number: 2124215-2024-82294
• Device Sequence Number: 11779971
• Product Code: LOX
• UDI-Device Identifier: 08714729783350
• UDI-Public: 08714729783350
• 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): 12/29/2024

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: 11/29/2024
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0028468841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Race: Asian