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

Model Number	6531
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient underwent a percutaneous coronary intervention on the stenosed targeted lesion was located in the tortuous and calcified hemostatic valve.A 12mm x 3.50mm nc quantum apex balloon catheter was advanced for treatment.However, during procedure outside, the balloon shaft broke.Since this occurred outside the patient and the hemostatic valve, the device was retrieved and unwound from the wire without harming the patient.The procedure was completed with another device.No complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 82.3cm from the strain relief.The separated ends were jagged and ovaled in shape indicating the device was kinked prior to separation.At 3cm proximal from the proximal portion of the separation, the hypotube of the device was kinked.There was contrast in the inflation lumen and blood in the balloon folds.The balloon was tightly folded.Product analysis confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported that a shaft break occurred.The patient underwent a percutaneous coronary intervention on the stenosed target lesion, located in the tortuous and calcified hemostatic valve.A 12mm x 3.50mm nc quantum apex balloon catheter was advanced for treatment.However, during preparation of the procedure outside the patient, the nc quantum apex balloon catheter shaft broke in the middle.The nc quantum apex balloon catheter was retrieved and unwound from the guidewire without harming the patient.The procedure was completed with another nc quantum apex balloon catheter.No 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: 17338159
• Report Number: 2124215-2023-37667
• Device Sequence Number: 6607978
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 02/14/2026
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0031054269
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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