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

Model Number	6531
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with coronary artery disease (cad).A comet ii pressure guidewire was selected and failed when plugged in to the link and was unable to obtain a wire pressure.The wire was then replaced with another comet ii and fractional flow reserve (ffr) was completed.During the same procedure, a 12mm x 3.50mm nc quantum apex balloon catheter was advanced for dilation.However, the balloon ruptured.The balloon was removed, and no device fragments left inside the patient.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the calibrated pressure gage to inflate the device.The device inflated to rated burst pressure and deflated with no issue.Product analysis could not confirm reported event as the device inflated to rated burst pressure and deflated with no issue.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with coronary artery disease (cad).A comet ii pressure guidewire was selected and failed when plugged in to the link and was unable to obtain a wire pressure.The wire was then replaced with another comet ii and fractional flow reserve (ffr) was completed.During the same procedure, a 12mm x 3.50mm nc quantum apex balloon catheter was advanced for dilation.However, the balloon ruptured.The balloon was removed, and no device fragments left inside the patient.The procedure was completed successfully.No patient complications were reported.

• 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: 17816498
• Report Number: 2124215-2023-52452
• Device Sequence Number: 12302327
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 06/20/2026
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0031864912
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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